VASOPTIC MEDICAL, INC. — Department of Health and Human Services SBIR Phase I: NIBIB

Description

ABSTRACT Commercially available endoscopes and laparoscopes today are sophisticated in their ability to capture high definition photographs and video feeds of the tissue underlying the probe tip, but lack the ability to provide information about the functional status of the same tissue. Therefore, surgeons performing laparoscopic surgeries often have to rely on subjective cues for decision making. For example, during a pediatric surgery undertaken to resect a portion of the colon while sparing the healthy regions, the surgeon could benefit from the ability to confirm that the resection margins are chosen optimally and that tissue perfusion and viability has been intact or restored. Leveraging proprietary speckle-based and spectroscopy-based imaging technology, this project seeks to develop the first endoscopic tool that will complement the view of the surgical site with information pertaining to blood flow and tissue oxygenation on an as-needed basis. Because functional information will be available without the need for administering any exogenous contrast agents, the advanced endoscopic tool is expected to be unobtrusive and seamlessly integrate into the surgical work flow. Further, the disposable probe design will eliminate the need for sterilization of the probe between uses reducing the risk of contamination and infection. During Phase I, we will overcome hardware and software design challenges in speckle imaging technology to realize a first-of-its-kind flow-measuring endoscope and characterize its performance using appropriate phantom flow systems. We will subsequently validate the prototypeandapos;s ability to perform endoscopic visualization of resting state and altered blood flow in a large animal model of laparoscopy. If successful, we anticipate undertaking a Phase II effort, during which we will make a robust and optimized tool for use in pediatric procedures such as bowel resection and Laddandapos;s procedure, and validate its benefits to the operating surgeon through experimentation in large animal models of pediatric bowel resection and manipulation. Having statistically demonstrated improved outcomes, we will develop a clinical grade prototype and obtain first- in-human data during a laparoscopic procedure. This project, thereby, aims to the lay the foundation of the next generation of endoscopy – functional endoscopy.RELEVANCE TO PUBLIC HEALTH Surgeons performing laparoscopic surgery could greatly benefit from visualizing the functional status of the tissue under the probe tip, and use such feedback in surgical decision making. The goal of our project is to develop novel endoscopic technology that obtains and presents information pertaining to blood flow and tissue oxygenation in the field of view without the need for any exogenous contrast agents. Such technology may be particularly useful in pediatric procedures.