LUMOS CATHETER SYSTEMS, INC. — Department of Health and Human Services SBIR Phase I: DESCRIPTION (provided by applicant): The peripherally inserted central catheter (PICC) is

Description

DESCRIPTION (provided by applicant): The peripherally inserted central catheter (PICC) is a ubiquitous tool used in hospitals worldwide to allow patients to more safely and efficiently receive strong medicines, concentrated nutrition and/or long-term intravenous fluids. PICCs begin in a peripheral vein, typically in the arm or leg, and are then advanced through a vein until the tip of the catheter arrives at a central location (i.e., a vein with sufficient diameter to allow for rapid dilution of the infused fluid). Despite its ubiquitous use, PICC insertion continues to be fraught with risk. Once the tip of the PICC penetrates the skin, the operator can no longer visualize the tip of the PICC, relying only on feel and estimated distance to judge where the catheter and tip are located. It is the blind nature of the catheter insertion that leads to improper insertions and resulting harm to cardiac and other body tissues. A novel approach pairing optical fiber technology with specific visible wavelengths oflight that transilluminate through tissue enables the Lumos Real Time Visualization (RTV) system to improve the safety and efficacy of PICC insertion. The Lumos RTV system replaces the traditional plastic stylet with a Lumos optical fiber stylet. A customLED light source is coupled to the proximal end of the optical fiber stylet and conducts light down the length of the optical fiber and through specific windows manufactured in the optical fiber stylet. Light exits the optical fiber, transilluminates through the catheter and tissue and provides the medical professional with real-time information on the internal catheter course and tip location. Lumos uses a proprietary combination of visible wavelengths with optimized for tissue transillumination to give accurate position and depth information to the user's naked eye. The Lumos approach to catheter visualization is particularly well suited for smaller patients, e.g., neonatal and young pediatric, which will be the focus of the development and commercialization efforts of the company in the near term. The specific aims detailed in this SBIR proposal address essential development projects. First, Lumos proposes to further optimize the design of a visible transilluminating PICC catheter and specifically the following components of the system: RTV optical fiber stylet, deep tissue-penetrating light source and a highly translucent PICC catheter. Furthermore, Lumos will test the safety and performance of the RTV system -- first in cadaver tissue and ultimately inanimals. With the SBIR projects funded and complete, the Lumos RTV will be poised to enter the final phase of testing toward FDA regulatory approval and clinical use in human patients. PUBLIC HEALTH RELEVANCE: The projects proposed in this SBIRwill lead in part to the development and commercialization of the Lumos Real Time Visualization system - a safer, more cost and time efficient method for the insertion of invasive catheters.