Safe urinary catheter and manufacturing method

A method of manufacturing a urinary catheter for draining urine from a bladder of a patient, the method comprising:

• providing an elongate, flexible, tubular catheter shaft having a proximal end and a distal end and consisting of silicone and further comprising:
• a primary lumen extending through the catheter shaft from a fluid inlet at or near the distal end of the catheter shaft to the proximal end of the catheter shaft;
• and
• an inflation lumen extending through the catheter shaft from a distal filling hole near the distal end of the catheter shaft to the proximal end of the catheter shaft;
• attaching a connector with the proximal end of the catheter shaft, wherein the connector comprises:
• a first arm in fluid communication with the primary lumen and ending in a fluid outlet configured to allow urine to flow out of the urinary catheter;
• and
• a second arm comprising an aperture in fluid communication with the inflation lumen and ending in an inflation inlet used for introducing inflation fluid into the urinary catheter;
• mounting a retention balloon on the catheter shaft over the distal filling hole and proximal to the fluid inlet, wherein the retention balloon is made of silicone, has a non-tubular, preformed balloon shape when not inflated, and has a first wall thickness and a first durometer;
• and
• mounting a tubular pilot balloon consisting of a tubular member on the second arm of the connector over the aperture in the second arm in a location that is outside the patient during use of the urinary catheter, wherein the pilot balloon is made of silicone, has a tubular shape when not inflated and thus has a higher threshold opening pressure than that of the retention balloon, and has a second wall thickness that is greater than the first wall thickness and a second durometer that is greater than the first durometer,
• wherein the retention balloon is configured to inflate at a first inflation pressure, and the pilot balloon is configured to inflate at a second inflation pressure that is higher than the first inflation pressure and lower than a predetermined pressure threshold.

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 that a pilot balloon at or near a proximal end of the urinary catheter, located outside the patient, has inflated;
• waiting for at least a predefined amount of time for the pilot balloon to deflate;
• and
• if the pilot balloon deflates during the predefined amount of time, then leave the urinary catheter in place within the patient;
• and
• if the pilot balloon does not deflate during the predefined amount of time, then:
• removing the inflation fluid from the urinary catheter;
• and
• repositioning or removing the urinary catheter.