Very Low-Cost C-Scan Ultrasonic Imaging

Period of Performance: 09/30/2006 - 08/31/2007

$590K

Phase 2 STTR

Recipient Firm

Pocketsonics
941 Glenwood Station Lane
Leesburg, VA 20176
Principal Investigator

Abstract

DESCRIPTION (provided by applicant): The goal of this program is to save lives and improve the quality of care of people requiring vascular access by enabling quicker access and minimizing failed attempts. Direct visualization of target vessels with ultrasound imaging will minimize number of attempts and failed attempts, thus allowing more rapid vascular access for administration of IV fluids or medications, improving patient satisfaction, reducing the need for more invasive procedures and saving healthcare providers' valuable time. This program will make ultrasound guided vascular access available to a greater number of healthcare providers in a wide range of settings by developing and validating a low-cost ($2,000 per unit), easy to use, and highly portable ultrasonic imaging system called the Sonic Window. This system will be comparable in size to a mobile phone or PDA and is specifically designed to meet the needs of users with little or no experience in medical imaging at a fraction of the cost of currently available portable ultrasound systems. Our system will form C-Scan images (image plane parallel to skin surface) that are intuitive for novice users and display those images at the site of acquisition, allowing the user to see the image in the perspective that would be obtained if you had a clear 'window' through the skin into the tissue or vessel of interest. The Sonic Window is being realized by combining a low profile 2D array, custom integrated circuits, novel beamforming and image processing algorithms implemented on a commercial Digital Signal Processor, and a LCD display. Innovative technological approaches are employed to circumvent conventional engineering wisdom that holds that C-Scan imaging is inherently more complex and costly than B-Scan imaging (plane perpendicular to skin surface). The Specific Aim of this Phase II research is to demonstrate the efficacy of a prototype Sonic Window system for guiding peripheral IV access procedures. This aim will be accomplished through 2 clinical studies involving nurses which compare the success of ultrasound guided peripheral IV insertions with the prototype to landmark based peripheral IV insertions (control). The first study will be comprised of known difficult to access patients (i.e. 1 failed access attempt) requiring IV placement. The second study will be comprised of patients requiring IV placement from a nursing unit with a population of patients generally regarded to have difficult access (e.g. bariatrics, oncology, ICU). In order to perform the studies, we will first complete integration of a clinical Sonic Window prototype and perform system validation, optimization and safety verification. A positive conclusion from this research, demonstrating faster and easier peripheral IV access, will increase confidence in the commercial viability of the Sonic Window product. In future stages of development, we will extend this work to include more complicated access procedures such as central line insertions. This research is a collaborative effort between PocketSonics, Inc. and the University of Virginia (Departments of Biomedical Eng., Electrical and Computer Eng. and the School of Nursing). The goal of this program is to save lives and improve the quality of care of people requiring vascular access by enabling quicker access and minimizing failed attempts. Direct visualization of target vessels with ultrasound imaging will minimize number of attempts and failed attempts, thus allowing more rapid vascular access for administration of IV fluids or medications, improving patient satisfaction, reducing the need for more invasive procedures and saving healthcare providers valuable time. This program will make ultrasound guided vascular access available to a greater number of healthcare providers in a wide range of settings by developing a low-cost ($2,000 per unit), easy to use, and highly portable ultrasonic imaging system called the Sonic Window.