James Ansell, MD, Neil Warren, Dr, Pete Wall, Dr, Kim Cocks, Dr, Stuart Goddard, Dr, Michael Stechman, Mr, David Scott-Coombes, Mr, Jared Torkington, Mr. Welsh Institute for Minimal Access Therapy, Cardiff, UK. University Hospital of Wales, Cardiff, UK..
Objective of the technology or device
Surgical smoke obscures the operative view and chronic inhalation may have health implications for operating room (OR) personnel. UltravisionTM is a new device that utilises electrostatic precipitation to clear surgical smoke during laparoscopic procedures.
Description of the technology and method of its use or application
The UltravisionTM device can be connected to any standard electrosurgical system. A 15cm IonwandTM is inserted percutaneously through a hollow needle, adjacent to the operative site. The IonwandTM is a stainless steel microfilament brush equivalent in size to a veress needle. The device is placed into the abdomen, under direct vision following the insertion of the laparoscopic camera. The IonwandTM does not interfere with operation itself and the puncture site does require any additional closure methods. A DC voltage (9kV) is applied to wand which leads to the release of Ions which in turn, collide with particles of surgical smoke, transferring a negative charge. These negatively charged smoke particles are then attracted to the nearest earthed or positively charged surface, which in laparoscopic surgery is the internal abdominal cavity. This process clears smoke away from the operative field in an efficient manner.
Results are presented from the first clinical trial using UltravisionTM. Patients undergoing laparoscopic cholecystectomy were randomised into “active (device on)” or “control (device off)”. Three operating surgeons scored the percentage effective visibility and 3 reviewers scored the percentage of the procedure where smoke was present. All assessors also used a 5-point scale (1=imperceptible/excellent and 5=very annoying/bad) to rate visual impairment. Secondary outcomes were the number of smoke related pauses, camera cleans and pneumoperitoneum reductions. Mean results are presented with 95% Confidence Intervals (CI).
Preliminary results if available
In 30 patients (active n=13, control n=17) the effective visibility was 89.2% (83.3-95.0) for active cases and 71.2% (65.7-76.7) for controls. The proportion of the procedure where smoke was present was 41.1% (33.8 to 48.3%) for active cases and 61.5% (49.0 to 74.1) for controls. Operating surgeons rated the visual impairment as 2.2 (1.7 to 2.6) for active cases and 3.2 (2.8 to 3.5) for controls. Reviewers rated the visual impairment as 2.3 (2.0 to 2.5) for active cases and 3.2 (2.8 to 3.7) for controls. In the active group, 23% of procedures were paused to allow smoke clearance compared to 94% of control cases. Camera cleaning was not needed in 85% of active procedures and 35% of controls. The pneumoperitoneum was reduced in 0% of active cases and 88% of controls.
Conclusions / future directions
UltravisionTM improves visibility during laparoscopic surgery and reduces delays in surgery for smoke clearance and camera cleaning. Preventing active dissipation of smoke into the OR when using the instrument may have significant protective implications for both surgeon and theatre staff by minimising chronic exposure to surgical smoke. Future work will be directed towards the commercialisation of the UltravisionTM.
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