Patent Publication Number: US-2021162169-A1

Title: Method of using a catheter with a dedicated flushing port

Description:
BACKGROUND OF THE INVENTION 
     The use of a catheter to drain the bladder has been known for over 3500 years. The word catheter is of Greek origin meaning to “let down” and referred to any device that was inserted into the body. There is documentation that ancient Syrians used reeds inserted into the urinary track to relieve a blocked bladder. Benjamin Franklin invented a silver catheter that he used to help his older brother that suffered from kidney stones. 
     Infection was a common but serious problem with these catheters. Eventually, the medical community came to realize that sterilization is extremely important whenever introducing anything into a human body. Additionally, flexible catheters were safer and more comfortable, but were more difficult to produce until advances in science gave us suitable materials. Modern urinary catheters are very flexible and come sterilized until ready for use. 
     In use, catheters may need to be irrigated to cleanse the bladder, tubing and to remove any blood clots that may form. In order to be irrigated, the user must disconnect an irrigation bag and then inject a sterile saline solution to flush the catheter system and then reconnect the irrigation bag. This procedure presents additional risks for infection and contamination when using the catheter. There is a need for a catheter that reduces the risk for infection by allowing the catheter to be irrigated and flushed without having to disconnect and reconnect the irrigation tube. 
     SUMMARY OF THE INVENTION 
     A catheter with a dedicated flushing port has a flushing port that allows the practitioner to irrigate an inserted catheter to remove blood clots and other substances from the patient without removing the drainage tube. A holder keeps the flushing port clean and while not in use. A drainage bag with a large spout is provided to allow easy empting of the drainage bag. In one embodiment, the flushing port is integrated as part of the catheter. In another embodiment, the flushing port is part of the drainage tubing and in another embodiment, the flushing port is provided as an attachment piece that fits between the catheter and the drainage tubing. The drainage bag has a handle that allows the user to tip the bag to empty. 
     Other features and advantages of the instant invention will become apparent from the following description of the invention which refers to the accompanying drawings. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         FIG. 1  is an illustration of prior art catheter setup using a syringe and flushing tray. 
         FIG. 2  is an illustration of a catheter with dedicated flushing port setup according to an embodiment of the invention. 
         FIG. 3  is an illustration of the catheter with dedicated flushing port shown in  FIG. 1 . 
         FIG. 4  is an illustration of the catheter with dedicated flushing port shown in  FIG. 3  with flushing port in a storage configuration. 
         FIG. 5  is an illustration of a catheter with dedicated flushing port according to an embodiment of the invention. 
         FIG. 6  is an illustration of the catheter with dedicated flushing port shown in  FIG. 5  with flushing port in a storage configuration. 
         FIG. 7  is an illustration of the catheter with dedicated flushing port shown in  FIG. 2  with an irrigation syringe inserted in the flushing port 
         FIG. 8  is an illustration of the catheter with a with flushing port according to an embodiment of the invention. 
         FIG. 9  is a detailed view of the drainage bag shown in  FIG. 2 . 
         FIG. 10  is a view of the drainage bag shown in  FIG. 9  with sealable drainage spout in an open configuration 
         FIG. 11  is a view of a two-way catheter with dedicated flushing port according to an embodiment of the invention. 
         FIG. 12  is a view of a one-way catheter with dedicated flushing port according to an embodiment of the invention. 
         FIG. 13  is front view of the flushing port shown with holder shown in  FIG. 4 . 
         FIG. 14  is a perspective view of the flushing port with holder shown in  FIG. 4 . 
     
    
    
     DETAILED DESCRIPTION OF THE INVENTION 
     In the following detailed description of the invention, reference is made to the drawings in which reference numerals refer to like elements, and which are intended to show by way of illustration specific embodiments in which the invention may be practiced. It is understood that other embodiments may be utilized and that structural changes may be made without departing from the scope and spirit of the invention. 
       FIG. 1  shows a prior art catheter system in a typical setup with a continuous bladder irrigation bag (CBI)  125  attached using an irrigation tubing  155  which is attached to an irrigation port  120  disposed on a catheter  110 . A drip chamber  127  and roller clamp  128  is typically used to control the flow of the irrigant. A drainage tubing  150  is attached to a drainage port  130  on catheter  110 . Drainage tubing  150  is attached to catheter  110  and a drainage bag  135  is used to collect the urine when properly inserted into the urinary track of a patient (not shown). During use, the catheter must be flushed to remove blood clots and other substances that can build up. In order to flush the system, drainage tubing  150  must be removed and carefully placed to keep it clean and sterile. An irrigation syringe  180  is used to flush the system with a sterile solution and a tray  185  is placed under drainage port  130  to catch the flushing fluids as they flush from the system. Great care must be used to keep from introducing any bacteria or infectious agents into the system during this procedure. Once flushed, drainage tubing  150  is reconnected until flushing is needed and the procedure is repeated. In general, flushing a prior art catheter is one of the most frequent sources of contamination and infection in the patient. 
     Referring to  FIGS. 2-4, 7, 9-10 and 13-14 , a catheter with dedicated flushing port system  100  is shown using 3-way catheter  110  has an end which is inserted in a patient (not shown) and held in place with an inflatable balloon portion  115  as is known in the art. Inflatable balloon portion  115  is inflated and deflated using a balloon fill port  160 . In use, continuous bladder irrigation bag  125  is connected to irrigation port  120  to supply the irrigant using irrigation tubing  155  along with drip chamber  127  and roller clamp  128  as described above. A catheter drainage tube with dedicated flushing port  170  is connected to drainage port  130  on catheter  110 . A dedicated flushing port  140  is provided to allow the user to flush catheter  110  without the necessity of disconnecting and then reconnecting catheter drainage tube with dedicated flushing port  170 . A drainage bag  190  is connected using catheter drainage tubing with dedicated flushing port  170 . 
     Drainage bag  190  has a sealable drainage spout  192  that is sealed using a hook and loop fastener  198 . Sealable drainage port  192  is large enough to easily allow blood clots and other collected substances to be removed by opening sealable drainage spout  192  and tipping drainage bag  190  using a handle  195 . Once drained, sealable drainage spout  192  is resealed. Of course other resealable means may be used to seal drainage bag  190  as long as sealable drainage spout  192  is resealable. A flushing port holder  145  allows dedicated flushing port  140  to be sanitarily stored while not in use. A clamp  165  is used to clamp off dedicated flushing port  140  when not in use. 
     When flushing is required, dedicated flushing port  140  is removed from holder  145  and irrigation syringe  180  is filled with irrigant solution such as a saline solution and then inserted in dedicated flushing port  140  where the irrigant is injected and then clamp  165  is used to clamp off dedicated flushing port  140 . Of course other clamping means may be used to control the flow fluids as is known in the art. The flushing fluid irrigates the urinary track of the patient and then flows out through drainage port  130  and is directed down through catheter drainage tube with dedicated flushing port  170  and into drainage bag  135  without the need to open the system up, thus reducing the likelihood of external contamination and infection. The system may be flushed as needed by repeating the procedure. When flushing is complete, dedicated flushing port  140  is placed in holder  145  until needed. 
     Referring now to  FIGS. 5 and 6 , a catheter with integral dedicated flushing port  175  is shown having an elongated drainage port portion  133  with a dedicated flushing port  142  and a holder  147  to secure dedicated flushing port  142  when not in use. Again clamp  165  is used to control fluid flow. An irrigation port  122  and balloon fill port  162  are provided to be used as described above.  FIG. 6  illustrates the non-use storage position with dedicated flushing port  142  retained in holder  147 . 
     Now referring to  FIG. 8 , a flushing port attachment  112  is attached to catheter  110  using drainage port  130  and then drainage tubing  150  is attached to a drainage port  134  located on flushing port attachment  112 . A dedicated flushing port  144  is provided to allow the user to flush the system without detaching drainage tubing  150  as described above. As discussed above, flushing port  144  is removed from a holder  148  which allows the user to flush the system without having to detach the drainage tube. 
     Referring to  FIG. 11 , a two-way catheter  102  is shown having a drainage port  131  and a balloon fill port  161 . Catheter drainage tube with dedicated flushing port  170  is inserted in drainage port  131 . As discussed above, flushing port  140  is removed from holder  145  and allows the user to flush the system without having to detach the drainage tube. 
     Now referring to  FIG. 12 , a one-way catheter  103  is shown having a drainage port  136 . Flushing port attachment  112  is attached to catheter  103  using drainage port  134  and then drainage tubing  150  is attached to a drainage port  134  located on flushing port attachment  112 . Dedicated flushing port  144  is provided to allow the user to flush the system without detaching drainage tubing  150  as described above. 
     Signs and Symptoms of a Blocked Catheter
         No urine flow from the catheter.   Suprapubic distention and lower abdominal pain becoming more pronounced as the bladder fills.   Urine leaking around the catheter (bypassing).   Vaso-vagal symptoms may develop i.e, sweating, tachycardia and hypotension if the blockage is unrelieved.   Autonomic dysreflexia in Spinal Cord Injured (SCI) patients.       

     Optimal Outcome
         The dots are removed frog bladder and the urine is draining freely.       

     Sub-Optimal Outcomes
         Over distention of the bladder.   Inability to unblock the IUC and requiring catheter replacement.   Development of a catheter associated urinary tract infection (CAUTI) secondary to contamination during the procedure and break in the closed urinary drainage system.       

     Equipment
         Alcohol based hand rub.   70% alcohol swabs.   1 bottle 500 mL sterile sodium chloride 0.9% (Normal Saline).   Disposable under pad.   Non-sterile receptacle.   Irrigation set (60 ml syringe and wide top bottle to hold irrigant).   1 pair of sterile gloves   Personal Protective Equipment (PPE) protective eyewear, plastic apron/disposable gown and gloves (if required by policy)       

     Procedure
         Perform hand hygiene.   Explain procedure to patient, obtain consent and identify allergies.   Ensure patient privacy.   Position patient in supine position, allow for easy access.   Place a disposable sheet under the work area.   Place non-sterile jug/receptacle nearby.   Clamp off CBI on irrigation tubing.   Perform hand hygiene.   Pour sterile chloride 0.9% into irrigation receptacle.   Perform hand hygiene.   Put on gloves.   Draw up 50 mL of sodium chloride 0.9% in syringe.   Remove flushing port from holder.   Clean flushing port well with the 70% alcohol swabs and discard swab.   Insert syringe into flushing port, and unclamp clamp.   Using 50 mL volumes of sodium chloride 0.9%, irrigate catheter by flushing in and drawing back on the plunger to evacuate any clot or debris.       

     Warn the patient that this will be painful/uncomfortable. If resistance is encountered reasonable pressure can be used (except following renal transplant or bladder surgery).
         Empty each syringe directly into the non-sterile jug/receptacle or allow to flow down drainage tubing.   Continue to irrigate with 50 mL volumes until drainage runs clear or a clot free return is achieved.   Clamp off flushing port using clamp.   Clean flushing port with alcohol.   Replace flushing port into holder.   Recommence continuous bladder irrigation by unclamping tubing.   Remove disposable sheets and ensure that the patient is comfortable.   Remove personal protection equipment (PPE).   Dispose waste according to local policy.   Perform hand hygiene.   Calculate the difference between volume in and volume returned.       

     Document outcome in patient clinical progress notes including:
         Date and time of procedure.   Indication for the procedure including the patients clinical signs and symptoms.   Outcome i.e. color and type of drainage, presence of dots and patients tolerance of the procedure.   Record on the fluid balance chart volume in the volume return.       

     Although the instant invention has been described in relation to particular embodiments thereof, many other variations and modifications and other uses will become apparent to those skilled in the art.