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SBIR Phase I: Low-cost needle guidance system for bedside lumbar puncture

Award Information
Agency: National Science Foundation
Branch: N/A
Contract: 1938039
Agency Tracking Number: 1938039
Amount: $225,000.00
Phase: Phase I
Program: SBIR
Solicitation Topic Code: MD
Solicitation Number: N/A
Timeline
Solicitation Year: 2019
Award Year: 2020
Award Start Date (Proposal Award Date): 2020-01-15
Award End Date (Contract End Date): 2020-07-31
Small Business Information
7920 WENTWORTH DR, DULUTH, GA, 30097
DUNS: 116767452
HUBZone Owned: N
Woman Owned: N
Socially and Economically Disadvantaged: Y
Principal Investigator
 Cassidy Wang
 (614) 795-1281
 cassidy@ethos-medical.com
Business Contact
 Cassidy Wang
Phone: (614) 795-1281
Email: cassidy@ethos-medical.com
Research Institution
N/A
Abstract
The broader impact of this Small Business Innovation Research (SBIR) Phase I project is to improve the quality and efficiency of spinal access procedures by developing a needle guidance system that attaches to ultrasound machines. Lumbar punctures (LPs) are procedures used to diagnose and treat neurological conditions such as meningitis, multiple sclerosis and others. Without prompt intervention, meningitis infections can be fatal within days. During an LP, fluid must be collected from the center of the spine for diagnosis. The procedure can be challenging, costly, and time-consuming and is subject to practitioner experience and patient body type. Practitioners must manually feel for spinal landmarks at the skin surface to position the needle, then blindly insert into the spine. Up to 42% of procedures fail to access the target. In these cases, patients are referred to the Radiology department for an x-ray guided LP, which increases the cost of care, lengthens patient stay, and exposes the patient to radiation. The proposed research aims to develop a needle guidance system that enables spinal access procedures to be performed under real-time ultrasound imaging. By allowing providers to continuously monitor the needle’s trajectory, the proposed system can significantly improve first-attempt success rates. The proposed project aims to demonstrate the feasibility of a low-cost needle guidance system that interfaces with ultrasound equipment in bedside environments. Problems associated with LPs can be attributed to two primary causes: (1) the practitioner often cannot be certain of the target’s location and the needle’s trajectory; and (2) effective use of ultrasound imaging equipment as an alternative to the traditional blind technique relies on practitioner expertise in interpreting spinal ultrasound, which is rare in bedside settings. To remedy the first deficiency, the proposed system will consist of a needle-guiding attachment for an ultrasound probe and a software overlay that displays the needle’s trajectory on top of the ultrasound image. To address the barrier of ultrasound expertise, the software will also incorporate an anatomy recognition algorithm, displaying interpretable spine renderings corresponding to the imaged region. The proposed research will evaluate the needle trajectory prediction accuracy of the system in bench, cadaver, and live tissue models, ensuring minimal prediction error so the needle can consistently be guided to the target. Anatomy recognition software will be developed using images captured from the tissue models with the aim of correctly identifying important anatomical landmarks in at least 93% of cases. This award reflects NSF's statutory mission and has been deemed worthy of support through evaluation using the Foundation's intellectual merit and broader impacts review criteria.

* Information listed above is at the time of submission. *

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