Thomas B Ferguson Jr, Adjunct Professor, Chief Medical Officer1, Cheng Chen, PhD, Chief Technology Officer1, Bryent Tucker, MSBE1, Jeffery Basham, MBA, CEO2. 1East Carolina Diabetes and Obesity Institute, 2RFPi, Inc.
Objective of the Technology: Light in the visible spectrum guides surgical decision-making by enabling the surgeon to intraoperatively define anatomy. Ionizing radiation (catheterization, CT) and MRI help to preoperatively define pathology. Across surgical sub-specialty major procedures, however, most serious complications involve the unrecognized compromise of the physiology of tissue perfusion and tissue integrity. Incidences of 5-15% for these major procedures are reported in the literature.
Technologies to image intraoperatively the physiology of blood flow distribution (vessel flow and tissue perfusion) have been absent until recently. Those available are invasive, time-consuming and distruptive to the procedural flow. Real-time visualization of blood flow distribution in vessels and tissues is an unmet need, if surgeons are to evolve from 'guessing' to objective identification, quantification, and intra-procedure remedy.
Description of Technology and Method of Use: We describe Multi-Spectral Physiologic Visualization (MSPV), from RFPi, Inc. The first form factor of this patented platform technology is iCertainty, for open surgical procedures. The iCertainty MSPV technology solution is a combination of illumination wavelengths, reflectance imaging and augmented laser speckle contrast analyses. Differentiators of this technology solution are: 1) non-invasive (no dyes, contrast agents, drugs); 2) non-contact; 3) no ionizing radiation; 4) Class 1M laser device, safe for use even with multiple imaging episodes/procedure; 5) analyzed imaging data at t0, so imaging acquisition sequence is only 10-20 sec; 6) true real-time visualization (imaging acquisition and analysis) displayed for the surgeon; 7) visible light image (anatomic detail) and MSPV (physiology of blood flow distribution 'fused' to the same anatomic detail) always presented to the surgeon; 8) relative quantification of blood flow distribution.
iCertainty is a mobile care-based form factor placed on the assistant's side of the operating table; the extension arm with the Optical Head Unit is covered with a sterile drape and extends over the operative field. Up to 10 imaging Episodes (accepted imaging acquisition sequences) can be captured for each Case by the iCertainty software. Total time (positioning, acquisition, display) / Episode is < 30 sec, minimizing interruption of the procedural flow.
Preliminary Results: MSPV displays the relative dynamic physiology of blood flow distribution in vessels and in tissues, in video format for the surgeon's real-time assessment. MSPV data augments the standard of care surgeon decision-making porcesses of visible light inspection, knowledge, training and judgment. MPSV has imaged blood flow distribution in > 15 tissue types thus far. The iCertainty MSPV form factor was approved as a Class II device through the 510(k) process by the FDA in December, 2018. The approval covers intended use where the surgeon feels blood flow and prfusion determiantion might impact clinical outcomes; it is not sub-specialty specific or procedure specific.
Future Directions: Additional form factors for minimally invasive procedures are in development. RFPi's iCertainty imaging technology to visualize blood flow distribution (flow and perfusion) in tissues will importantly augment the surgeon standard of care decision-making process. Better decisons –> fewer complications –> better outcomes –> low healthcare costs.
Presented at the SAGES 2017 Annual Meeting in Houston, TX.
Abstract ID: 98785
Program Number: ETP775
Presentation Session: Emerging Technology Poster Session (Non CME)
Presentation Type: Poster