The setup can be minimal for our system. Just like an IV placement where drapes and sterile gloves are not needed, our catheter can be inserted without ever touching the portion of the catheter that is inserted into the body. Even if a facility’s protocols require a sterile setup for any catheter placement, the catheter insertion time is the same as a single injection procedure at that institution. This simple setup can save 5-10 min off of the procedure time.
The skills needed are the same as a single injection procedure. No need to thread a catheter through the needle and remove the needle without dislodging the catheter. Withdrawing the needle in our catheter system means simply pulling the needle back while advancing or holding the catheter with the tip of your index finger. This is the same an IV placement technique which all anesthesiologists know how to do. Securement is similar to an IV securement as well. This entire procedure would typically take someone 5 min on average from start to finish.
Since our catheter is over the needle and thus a larger bore than the needle, the tissue wraps tightly around the catheter so there is no space for leakage. Our catheter also has an integrated hub because the needle can be withdrawn without the catheter hub getting in the way. This also reduces the chance for the hub to leak and reduces another step of connecting a hub.
Our method can also be performed with a single hand so the ultrasound image is always maintained and an assistant is not required. The catheter is constantly viewed so the tip position is never lost. The efficacy is greatly improved because you know precisely where the catheter is located at all times.
Essentially, our catheter can be placed as quickly as a single injection procedure (approx. 5 min on average from start to finish), with less skill requirements and without assistance.
Solo-Dex has FDA Clearance and the CE Mark, 1 issued US patents and 4 patents pending and has currently rolled out the product for use by key opinion leaders.