Evaluation of Adjacent Tissue Thermal Damage When Using the Low Power JustRight Surgical(r) Vessel Sealing System

Suzanne M Yoder, MD, Jenifer Kennedy, PhD, Allison Lyle, MS, Alison Bendele, DVM, PhD. JustRight Surgical

Objective of the Technology:

Performing neonatal and pediatric minimally invasive surgery requires fine dissection and vessel sealing in small spaces. Standard laparoscopic instrumentation is available in 3mm size. However, vessel sealing technology has traditionally required a larger, 5mm instrument tip. These 5mm sealers are often too bulky for fine dissection and do not fit or function well in the small chest and abdominal cavities of infants and children.

The JustRight Sealer® is a 3mm vessel sealer with a fine, dissecting tip that allows delicate access to these spaces. As with any sealer, when working in a small field, inadvertent contact with adjacent tissue is a possibility. Our study evaluates the potential thermal damage to adjacent tissue when using the JustRight Sealer.

Description of the Technology

The JustRight Surgical Vessel Sealing System is a unique low power radiofrequency vessel sealing system. It features 3mm laparoscopic instrument with bilateral dissecting jaws, short seal times (<2 seconds average), a low thermal mass, and delivers only 25 Watts maximum power in contrast to existing systems that deliver 300 Watts maximum power. Correspondingly, the total energy delivered to the surgical site is significantly reduced. It is hypothesized that short seal times at low power result in insignificant damage to adjacent tissue structures even when deliberate direct contact is made.

Preliminary Results

A 21 day survival study on 3 juvenile piglets was completed to demonstrate that thermal damage to adjacent structures using the JustRight Sealer was not clinically significant. Thermal injury was created on 65 separate sites within the peritoneal and pleural cavities of each pig (195 total injury sites) by activating the JustRight Sealer on the vascular omentum while intentionally contacting critical structures with the back and side of the 3mm tip. The burn locations were photographed and marked with suture material. Thermal injury was created in this same manner on small bowel, liver, gastroepiploic vascular bundle, mesenteric vasculature and lung.

At necropsy, 100% of the 195 injury sites appeared normal. There was no visible evidence of thermal injury, hemorrhaging or lesions at any of the sites. Healing was found to be normal upon gross examination by a board certified veterinary pathologist. Histologic evaluation confirmed this result in that tissue appeared entirely normal upon microscopic evaluation.

The attached images are representative of surgery and necropsy images for liver and small bowel. It can be seen that there is visible blanching at the injury sites during surgery, but the tissue appears undamaged at 21 days post operatively.

Conclusion

While working in small tight, spaces, it is important to minimize any inadvertent injury to adjacent tissues. Our results demonstrate the safety of the JustRight Sealer as no evidence of any chronic thermal injury was visible in any of the 195 damage sites in our porcine model.