The carotid shunt is made up of a tube on the extremities of which the balloons are glued during the manufacturing process. Quality control (functionality test) are carried out in order to ensure that the product is conform. It has to be ensured that the balloons suffer no leaks.
What are the possible quality control test (non-destructive) that can be put in place after the assembly process to ensure conformity of the product ?
Sheik,
You could surely just inflate the cuff to a given pressure, valve off the gas supply, and monitor the change in pressure downstream of the valve.
(am I missing something?)
I tend to agree with Dr. Garry. During manufacture every 10th product should be tested by a competent technician, inflating the balloons to the recommended volume and seeing that they hold the air for a few hours.
Prior to actual use in surgery, the surgeon should make sure that he/she repeats the testing. Only this time it will only be for a few minutes. And it always pays to have a back-up Pruitt-Inahara shunt in the room.
Sheik,
Or, an even finer test would be to fill the balloon with a conductive liquid (brine, etc.) immerse the balloon in a bath of the same, and then measure the electrical resistance.
No need to wait, no need for fine pressure sensors.
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