Safe urinary catheter and manufacturing method

Abstract

A urinary catheter may include a catheter shaft and a connector coupled with the proximal end of the catheter shaft. The connector may have a first arm ending in a fluid outlet configured to allow urine to flow out of the urinary catheter and a second arm with an aperture and ending in an inflation inlet used for introducing inflation fluid into the urinary catheter. The catheter may further include a primary lumen, an inflation lumen, a retention balloon mounted to the catheter shaft proximal to a fluid inlet and over a distal filling hole, and a pilot balloon mounted on the second arm of the connector over the aperture. The pilot balloon inflates at an inflation pressure that is higher than the inflation pressure of the retention balloon and lower than a predetermined pressure threshold.

1 . A method of positioning a urinary catheter in a patient, the method comprising:
 advancing a distal end of the urinary catheter through the patient's urethra;   introducing inflation fluid into the urinary catheter to inflate a retention balloon at or near the distal end of the urinary catheter;   observing at least partial inflation of a pilot balloon at or near a proximal end of the urinary catheter, located outside the patient;   waiting for a predefined amount of time of less than ten seconds for the pilot balloon to deflate;   observing whether the pilot balloon deflates during the predefined amount of time;   based on the observing that the pilot balloon deflates during the predefined amount of time, leaving the urinary catheter in place within the patient.   
     
     
         2 . The method of  claim 1 , wherein:
 the retention balloon has a first length and a first threshold opening pressure; and   the pilot balloon has a second length that is greater than the first length and a second threshold opening pressure that is higher than the first threshold opening pressure.   
     
     
         3 . The method of  claim 1 , wherein waiting for the predefined amount of time for the pilot balloon to deflate comprises waiting for 3-10 seconds. 
     
     
         4 . The method of  claim 1 , wherein the pilot balloon has a durometer that is higher than a durometer of the retention balloon. 
     
     
         5 . The method of  claim 1 , wherein the pilot balloon has a wall thickness that is greater than a wall thickness of the retention balloon. 
     
     
         6 . The method of  claim 1 , further comprising visualizing at least the advancing the distal end of the urinary catheter via a radiographic imaging device and a radiopaque strip or marker on the urinary catheter. 
     
     
         7 . A method of positioning a urinary catheter in a patient, the method comprising:
 advancing a distal end of the urinary catheter through the patient's urethra;   introducing inflation fluid into the urinary catheter to inflate a retention balloon at or near the distal end of the urinary catheter;   observing at least partial inflation of a pilot balloon at or near a proximal end of the urinary catheter, located outside the patient;   waiting for a predefined amount of time of less than ten seconds for the pilot balloon to deflate;   observing whether the pilot balloon deflates during the predefined amount of time;   based on observing that the pilot balloon does not deflate during the predefined amount of time:
 removing the inflation fluid from the urinary catheter; and 
 one of repositioning or removing the urinary catheter. 
   
     
     
         8 . The method of  claim 7 , wherein:
 the retention balloon has a first length and a first threshold opening pressure; and   the pilot balloon has a second length that is greater than the first length and a second threshold opening pressure that is higher than the first threshold opening pressure.   
     
     
         9 . The method of  claim 7 , wherein waiting for the predefined amount of time for the pilot balloon to deflate comprises waiting for 3-10 seconds. 
     
     
         10 . The method of  claim 7 , further comprising, after repositioning the urinary catheter, introducing inflation fluid into the urinary catheter to inflate the retention balloon. 
     
     
         11 . The method of  claim 10 , wherein introducing the inflation fluid comprises injecting the inflation fluid with a syringe attached to an inflation port at or near the proximal end of the urinary catheter. 
     
     
         12 . The method of  claim 10 , wherein introducing the inflation fluid comprises injecting between 5 cc and 10 cc of the inflation fluid. 
     
     
         13 . The method of  claim 7 , wherein the pilot balloon has a durometer that is higher than a durometer of the retention balloon. 
     
     
         14 . The method of  claim 7 , wherein the pilot balloon has a wall thickness that is greater than a wall thickness of the retention balloon. 
     
     
         15 . The method of  claim 7 , further comprising visualizing at least the advancing the distal end of the urinary catheter via a radiographic imaging device and a radiopaque strip or marker on the urinary catheter.