Preclinical development of a novel coaptive vessel sealing device for liver resection

Abstract

Presenter: Lucas Thornblade MD, MPH | City of Hope Cancer Center Background: The safety of liver resection has increased dramatically, in great part due to advances in devices for parenchymal transection. We identified five limitations to existing vessel sealer technology: bulky jaws, short seal-zones, propensity for tissue shearing, tissue-char fouling, and the cost of fully disposable units. We sought to develop an affordable sealing device platform that could safely reduce the time required for open liver resection. Methods: We partnered with engineers to develop a radiofrequency (RF) powered coaptive sealing device with five features unique among existing vessel sealers. First, the device achieves a 6.5cm long seal zone, allowing faster parenchymal transection (Figure panel A). Second, lower-profile jaws reduce tissue tearing upon insertion into liver parenchyma. Third a spring-loaded hinge provides parallel apposition and reduces tissue shear. Fourth, the device applies saline to the sealing surface which reduces fouling upon repeated firings. And lastly, the reusable handle and low-cost RF generator facilitates an affordable alternative to conventional vessel sealers. The device was tested on 12 partial hepatectomies in six live canine models in compliance with 510(k) processes in an accredited large animal lab. Necropsy was performed 7-9 days postoperatively by a veterinary pathologist. Results: All subjects tolerated liver resection with minimal blood loss ( < 20cc). Figure panel B demonstrates a completed partial hepatectomy of the canine liver. Transaminases peaked by postoperative day four (mean ALT 194 U/L). At necropsy, no hematoma or bile collections were found. Novel design elements were registered with the U.S. Patent Office. Conclusion: By careful study of the limitations of existing designs, surgeons have a unique opportunity to impact changes in future surgical technology. Further work includes design refinement, regulatory overview for testing in humans, and partnership with industry.