Procedure

The Velomedix procedure is based on existing technologies and standard techniques, used on a daily basis in peritoneal dialysis and laparoscopic surgery. It consists of six distinct steps:

  1. Setting up the system
  2. Accessing the peritoneal cavity and inserting the cooling catheter
  3. Filling the cavity with chilled fluid
  4. Circulating chilled fluid to rapidly cool the patient to the desired temperature and then maintaining that temperature for the desired time
  5. Rewarming the patient slowly by circulating warm fluid in the cavity
  6. Removing the fluid from the cavity and retracting the cooling catheter

 

After the system is set up, the physician makes a very small incision near the umbilicus (belly button) and accesses the peritoneal cavity with a commonly available threaded cannula and a commonly used laparoscopic technique. He/she next inserts the proprietary, multi-lumen catheter into the peritoneal cavity and connects it to the temperature control system. This process usually takes about five minutes.

The next four steps are automatically performed by the controller system under minimal medical staff supervision. The system first fills the peritoneal cavity with a controlled volume of 0-5°C physiologically compatible solution. Next, the system circulates the fluid in the cavity, cooling it as necessary to decrease the patient’s temperature to below 35°C in less than fifteen minutes on average and then maintains the target temperature within 0.5°C for a prespecified period of time. Upon completion of cooling, the system irrigates warm fluid to gently raise the patient’s temperature at a slow and controlled rate. The system then automatically removes the fluid from the patient.

In the final step, the catheter is retracted from the patient and the incision is closed with steri-strips.