SBIR-STTR Award

HLS - Hand-Held Advanced Functional Imager for Assessing Local Tissue Oxygenation
Award last edited on: 1/29/18

Sponsored Program
SBIR
Awarding Agency
NIH : NHLBI
Total Award Amount
$1,620,058
Award Phase
2
Solicitation Topic Code
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Principal Investigator
Roman Kuranov

Company Information

Wasatch Photonics Inc (AKA: Wasatch Photonics Systems Division)

1305 North 1000 West Suite 120
Logan, UT 84321
   (435) 752-4301
   info@wasatchphotonics.com
   www.wasatchphotonics.com
Location: Single
Congr. District: 01
County: Cache

Phase I

Contract Number: 1R43HL127572-01
Start Date: 3/1/15    Completed: 8/31/15
Phase I year
2015
Phase I Amount
$149,950
We propose development of an advanced functional imager to assess red blood cell (RBC) transfusion. The prototype will be tested in a functional phantom during this SBIR Phase I project. The key features of the imager are the ability to quantify local tissue oxygenation with a handheld probe for easy tissue access. Our preliminarily market research indicates a strong demand for such instrument to help physicians effectively perform RBC transfusion, which is the most common inpatient hospital procedure. We hypothesize that non-invasive technology capable of providing repeated 3-D functional maps of tissue microvessels with diameters between 20-50 µm, where oxygen starts diffusing to the parenchymal tissues, will significantly decrease morbidity and mortality in RBC transfusion. Such technology has the potential to guide procedures by providing favorable information about optimal transfusion threshold, as well as evaluation of RBCs degradation with storage time and conditions. Current imaging technologies used to assess RBC transfusion include: Sidestream Dark Field (SDF), Orthogonal Polarization Spectral (OPS) and Near Infrared Spectroscopy (NIRS) do not provide 3-D maps of microvascular blood oxygenation and flow in a single microvessel with diameter 20-50 µm. SDF and OPS provide 2-D non-depth-resolved angiography and blood flow microvasculature information, thus missing the oxygenation information and arterioles and venules discrimination. The NIRS provides average arterial oxygenation information from a few square mm area and thus misses oxygen extraction, blood flow and spatial resolution. We propose to fill this gap with the proposed imaging technology for RBC transfusion assessment by combining multifunctional optical coherence tomography (OCT) and OPS in a single hand- held device. OPS offers real-time 2-D microvasculature map for user guidance purposes while multifunctional OCT provides 3-D microvasculature angiography and maps of blood flow and hemoglobin oxygen (O2) saturation (SO2) in single arterioles and venules as well as O2 extraction and relative oxygen consumption. We believe our approach provides the needed performance to solve a critical problem and a clear path to successful commercialization. This project will have strong social impact by providing critical clinical information to improve patient outcomes. Quantitative imaging of local tissue oxygen delivery and consumption will not only improve RBC transfusion outcome but has a great potential to decrease morbidity and mortality in many devastating diseases with vascular etiology including a variety of malignant, inflammatory, ischemic, infectious and immune disorders.

Public Health Relevance Statement:


Public Health Relevance:
The objective of this project is to create and test, in functional tissue phantom, a proof-of- principle prototype of an innovative, and cost-effective advanced functional imager to assess local tissue oxygenation. To construct an advanced functional imager we will combine in a convenient hand-held design Orthogonal Polarization Spectroscopy (OPS) with multimodal Optical Coherence Tomography (OCT) to provide 2-D and 3-D maps of microvasculature locations, hemoglobin oxygen saturation (SO2), blood flow, O2 extraction and relative oxygen consumption. The broader/commercial impact of the proposed project will be to understand the influence of the RBCs parameters on the outcome of the transfusion therapy and subsequently wider acceptance of advanced functional imager as a reliable monitoring tool that favorably influence clinician decision-making on patient's treatment including the need and parameters of blood transfusion. (End of Abstract)

Project Terms:
3-Dimensional; absorption; abstracting; Adhesions; Advanced Development; Anatomy; Angiography; Animal Model; Area; arteriole; Biological Markers; Blood; Blood flow; Blood Transfusion; Blood Vessels; Caliber; Clinical; clinically relevant; Code; Color; commercialization; Communicable Diseases; Consumption; cost effective; data acquisition; Decision Making; design; Devices; Diffuse; digital; Discrimination (Psychology); Disease; Erythrocyte Transfusion; Erythrocytes; Etiology; Evaluation; Eye; Hand; Hemoglobin; Hospitals; Image; Imaging technology; Immune; Immune System Diseases; improved; in vivo; indexing; Inflammatory; Injury; innovation; innovative technologies; Inpatients; instrument; interest; Lead; Letters; Location; Lung; Malignant - descriptor; Maps; Market Research; Marketing; Measurement; Measures; Mechanics; Methods; Microcirculation; Modality; Modeling; Modification; Monitor; Morbidity - disease rate; Mortality Vital Statistics; Mus; Nature; Near-Infrared Spectroscopy; Optical Coherence Tomography; Outcome; Oxygen; Oxygen Consumption; Patients; Performance; Phase; photonics; Physicians; portability; Positioning Attribute; Procedures; Property; prototype; public health relevance; Recurrence; Relative (related person); Resolution; Risk; Scanning; Skeletal muscle structure; Small Business Innovation Research Grant; Social Impacts; spectroscopic imaging; Spectrum Analysis; Technology; Testing; Time; tissue oxygenation; tissue phantom; Tissues; tool; Transfusion; Uncertainty; Universities; venul

Phase II

Contract Number: 2R44HL127572-02
Start Date: 3/1/15    Completed: 6/30/18
Phase II year
2016
(last award dollars: 2017)
Phase II Amount
$1,470,108

We believe that our project is responsive to the HLS16-02 Small Business Topic of Special Interest for NHLBI Fiscal Year 2016. Here, we will develop commercialization-ready advanced functional imager to assess red blood cell (RBC) transfusion. We successfully finished Phase I by developing the device’s prototype and testing its functionality in the proof-of-principle experiments in scattering phantom and two dorsal window mice models. In Phase II of the project the device will be verified with established functional microscopy in the dorsal window animal model, next the RBC transfusion microcirculation endpoint markers will be correlated with established organ wellness markers in the cranial window mouse model and finally the design and software of the clinically-ready imager will be finalized in a small study of volunteers. The key features of the imager are the ability to quantify local microcirculation parameters including tissue oxygen supply and consumption with a handheld probe for easy tissue access. Our market research and analysis indicates a strong demand for such instrument to help physicians effectively perform RBC transfusion, which is the most common inpatient hospital procedure. We estimate that our device can save annually up to $300 million in health care costs in the US. Currently there are no defined markers of the RBC transfusion efficiency evaluation, except the hemoglobin and hematocrit level, which do not address function. Conventional optimization of macrocirculatory (arterial blood pressure, cardiac output etc.) and tissue perfusion (acidosis, lactate, venous O2 saturation (SvO2), organ function etc.) parameters do not demonstrate beneficial results. We hypothesize that the microcirculation, including capillary density, blood oxygenation, flow and oxygen extraction in arterioles and venules with diameters of 20-100 µm, can provide crucial endpoints for optimization of the RBC transfusion. To reduce the risk of infection or injury in vulnerable patients and to minimize number of blood draws, a non-invasive microcirculation assessment, if validated, would be highly preferred over invasive or minimally invasive methods. We believe our approach provides the needed performance to solve a critical problem and a clear path to successful commercialization. This project will have strong social impact by providing crucial clinical information to improve patient outcomes. Quantitative imaging of local tissue oxygen delivery and consumption will not only improve outcomes with RBC transfusion but has great potential to decrease morbidity and mortality in many devastating diseases with vascular etiology including a variety of malignant, inflammatory, ischemic, infectious and immune disorders.

Public Health Relevance Statement:
Narrative The objective of this project is to test, in relevant animal studies and a small cohort of human volunteers, a commercialization-ready, innovative, and cost-effective advanced functional imager that was developed in Phase I to assess microcirculation tissue parameters in a clinical setting. The advanced functional imager combines in a convenient hand-held design, Orthogonal Polarization Spectroscopy (OPS) with multimodal Optical Coherence Tomography (OCT) to provide differentiated 3-D maps of arterioles and venules, hemoglobin oxygen saturation (SO2), blood flow and O2 extraction and consumption as well as functional capillary density (FCD). The broader/commercial impact of this project will be to utilize the microcirculation parameters in order to inform patient-specific decision on red blood cell (RBC) transfusion to improve outcome of transfusion therapy and lead to acceptance of the advanced functional imager as a reliable monitoring tool to assess RBC transfusion.

NIH Spending Category:
Bioengineering; Clinical Research; Diagnostic Radiology; Hematology; Networking and Information Technology R&D

Project Terms:
3-Dimensional; Acidosis; Address; Adhesions; Adoption; Adult; Anatomy; Angiography; Animal Model; Animals; arteriole; base; Blood; Blood capillaries; Blood flow; Blood Pressure; Blood Vessels; Brain; Businesses; Caliber; capillary; Cardiac Output; Cephalic; Clinical; Clinical Research; cohort; commercialization; Communicable Diseases; Computer software; Consumption; cost effective; Critical Care; Critical Illness; Data; data acquisition; density; design; Devices; Disease; Dorsal; Erythrocyte Transfusion; Erythrocytes; Etiology; Evaluation; Feedback; Goals; graphical user interface; Hand; Health Care Costs; healthy volunteer; Hematocrit procedure; Hemoglobin; Hospitals; Human Volunteers; Image; imaging modality; Immune System Diseases; improved; improved outcome; in vivo; Infection; Inflammatory; Injury; innovation; innovative technologies; Inpatients; instrument; Intensive Care Units; interest; Lead; Learning; Life; Malignant - descriptor; Maps; Market Research; Marketing; Measurement; Measures; Methods; Microcirculation; Microscopy; minimally invasive; Modification; Monitor; Morbidity - disease rate; mortality; mouse model; National Heart, Lung, and Blood Institute; Near-Infrared Spectroscopy; non-invasive imaging; Optical Coherence Tomography; Organ; Oxygen; Patient-Focused Outcomes; Patients; Performance; Perfusion; Phase; photonics; Physicians; portability; Positioning Attribute; Procedures; prototype; quantitative imaging; Recruitment Activity; Regulation; Research Personnel; research study; Resolution; Risk; Safety; Social Impacts; Software Design; software development; Spectrum Analysis; success; System; Testing; Time; Tissue imaging; tissue oxygenation; Tissues; tool; Transfusion; Universities; user-friendly; Venous; venule; volunteer; Wo