SBIR-STTR Award

Fluorescence Imaging Device with Edge Computing Capability for Intraoperative Vascular and Lymphatic Assessment
Award last edited on: 4/18/2023

Sponsored Program
SBIR
Awarding Agency
NIH : NHLBI
Total Award Amount
$599,863
Award Phase
1
Solicitation Topic Code
837
Principal Investigator
Maziyar Askarikarchegani

Company Information

Unify Medical (AKA: I-Imaging LLC)

30548 Royal Woods Place
Westlake, OH 44145
   (216) 309-8144
   N/A
   www.unifymedical.com
Location: Single
Congr. District: 16
County: Cuyahoga

Phase I

Contract Number: 1R43HL162327-01A1
Start Date: 9/1/2022    Completed: 2/29/2024
Phase I year
2022
Phase I Amount
$599,863
Assessment of vasculatures and lymphatics is critical to surgery. Fluorescence angiography is an excellent method for identifying anastomotic failure. Intraoperative detection of anastomotic failures and hypoperfusioncan reduce surgical re-exploration and follow-up surgery. For lymphatic surgery such as lymphovenousbypass, fluorescence lymphography is important for diagnosis, staging, and surgical planning. Unfortunately,commercially available fluorescence imaging systems are bulky, expensive, and not user-friendly. There is anunmet clinical need for an affordable and intuitive multiscale fluorescence imaging system suitable for diversevascular and lymphatic assessment use cases. The long-term goal is to improve outcomes of microvascular,lymphatic, transplant, and trauma surgery by enhancing intraoperative imaging and tissue assessment. Theoverall objective in this application is to develop a wearable multiscale fluorescence imaging and 3D displaydevice with edge computing capability. The project will be guided by the following specific aims: Aim 1.Develop a wearable multiscale fluorescence imaging and display device for vascular and lymphaticassessment. A compact prototype will be developed that offers real-time stereoscopic fluorescence imagingand 3D augmented reality display for vascular and lymphatic assessment. Multiscale fluorescence imagingwith 2X-10X dynamic magnification will be implemented to accommodate diverse surgical applications,including lymphatic mapping, perfusion angiography, and anastomosis patency testing. Heterogeneouscomputing will be implemented to support machine learning tasks using deep convolutional neural networks.Voice control and autofocus will be implemented on the edge. Medical information including duplex ultrasoundimages will be overlaid in augmented reality. Aim 2. Characterize the device and demonstrate wearablemultiscale fluorescence imaging in vivo. Comprehensively characterization of the system performance will beperformed. Wearable multiscale fluorescence imaging will be demonstrated in a rat model. Lymphatic mapping(wide-field fluorescence imaging) and an anastomotic patency check (magnified fluorescence imaging) will bedemonstrated in vivo. The proposed research is innovative, in applicant's opinion, because it represents asubstantive departure from the status quo by offering real-time multiscale fluorescence imaging capability andedge computing capability in a wearable 3D system. The proposed project is significant because it is expectedto provide strong evidence-based proof of principle for further development and future clinical trials of thewearable multiscale fluorescence imaging device for vascular and lymphatic assessment. If the proposeddevice is successfully commercialized, surgeons will have access to an innovative product that can improvesurgical outcomes of multiple surgical subspecialities.

Public Health Relevance Statement:
The proposed project is relevant to public health because it focuses on developing a novel intraoperative device for vascular and lymphatic assessment. Once such a device is developed and commercialized, surgeons will have access to an innovative product that can improve surgical outcomes. Thus, the proposed project is relevant to the part of the NIH's mission that pertains to reducing illness and disability.

Project Terms:

Phase II

Contract Number: ----------
Start Date: 00/00/00    Completed: 00/00/00
Phase II year
----
Phase II Amount
----
© Copyright 1983-2024  |  Innovation Development Institute, LLC   |  Swampscott, MA  |  All Rights Reserved.