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22 Phase I Selections from the 04.1 Solicitation

(In Topic Number Order)
CYBERNET SYSTEMS CORP.
727 Airport Boulevard
Ann Arbor, MI 48108
Phone:
PI:
Topic#:
(734) 668-2567
Dr. Charles J. Cohen,
OSD 04-DH1       Awarded: 24MAY04
Title:3D Haptic Femur Interface for Medical Training
Abstract:Medical personnel in training learn by practicing on real patients under supervision. Although effective, this approach is fraught with potential risks for both patient and trainee. Technological success involving other virtual training environments suggests that medical simulation has great potential to improve training time, quality, and efficiency; enhance patient care; and reduce medical risk and cost. This project will produce an examination/surgical simulation system prototype with a force feedback Haptic interface, modeled femur anatomy and tissue properties, and a virtual reality display that replicates the interactions of a surgical resident operating on a live patient. The specific aims are to: 1) develop force feedback Haptic surgical instruments; 2) model and simulate volumetric anatomic data from the Visible Human Project; 3) incorporate human tissue property measurements into anatomic models; 4) create a realistic interface consisting of the participant, Haptic tools, and virtual reality images; and 5) assess computational, force feedback, and display latency as well as Haptic and visual fidelity in order to simulate actual conditions during a surgical procedure. An integrated approach that takes the essential features of training in a real operating room and transforms them into the virtual environment will ensure DoD and market acceptance.

DIAMOND VISIONICS LLC
400 Plaza Drive, Suite-A, PO Box 1276
Vestal, NY 13851
Phone:
PI:
Topic#:
(607) 729-8526
Mr. Graham Upton
OSD 04-DH1       Selected for Award
Title:Fractured Femur Simulator
Abstract:Fractures of the femur have a very high incidence of catastrophic early and late complications. Prompt and judicious management of concurrent local visceral and systemic problems is essential. While training in proper techniques for these procedures is critical, finding acceptable models for realistic practice is difficult. There is a need to train large numbers of medical personnel in fracture management techniques. Learning of these procedures is required of combat medics and personnel, emergency medical personnel, nurses, and physicians. The solution to the need to for mass training is simulation technology. A high-fidelity PC-based training simulator is proposed here. The proposed simulator will provide visual feedback consistent with the visualization and manipulation of the fractured femur. It will train for multiple patient conditions and complications that might be encountered during the procedure. Cases and treatments presented in the training module will be based on embedded metrics for performance assessment and training. A user interface will contain a module that allows the teaching, rehearsal, testing and tracking the performance of the trainees. Phase I will result in a working prototype of the simulator.

DYNAMIC ANIMATION SYSTEMS, INC.
12015 Lee Jackson Highway, Suite 200
Fairfax, VA 22033
Phone:
PI:
Topic#:
(703) 503-0500
Dr. Jim Chung
OSD 04-DH1       Selected for Award
Title:Fractured Femur Simulator
Abstract:While medical simulation/training systems currently exist for a variety of specialties, there is no such system dealing with the assessment and treatment of fractured femurs. Suffered by hundreds of thousands each year, femur fractures can lead to serious consequences even when properly treated. When improperly treated by poorly-trained personnel, the risks of mortality and morbidity are much higher. This research effort will develop a fractured femur simulation/training system to provide hands-on training in management of femur fractures. The core of this system will be a detailed, realistic visual simulation of the injury site that will utilize state-of-the-art computer graphics technology. This visual core will be augmented by a software framework designed to accommodate various i/o devices and simulation models. The framework will facilitate the development of a family of training systems built around the same simulation core. The Phase I research will focus on three objectives: 1) enumeration of system requirements through an examination of design issues, 2) feasibility analyses of visual simulation technology using a suite of tools developed by Dynamic Animation Systems, and 3) generation of a plan for prototype development which will include preliminary system design and development schedule, and risk analysis.

IMMERSION CORP.
801 Fox Lane
San Jose, CA 95131
Phone:
PI:
Topic#:
(301) 984-3706
Dr. Kevin Kunkler
OSD 04-DH1       Selected for Award
Title:Fractured Femur Simulator
Abstract:Fractures of the femur occur in approximately 1 per 10,000 of the general population 3 per 10,000 in individuals aged less than 25 and over 65 years (Ertl, 2002). Studies have shown that fractures of long bones, especially hip and femur, account for the highest percentage of all injuries (Champion et al, 2003). Femur fractures result in significant time lost from work/school and disabling physical damage. Immersion Medical is submitting a proposal to design and implement a femur fracture simulator that will assist health care professionals in assessing, diagnosing, designating treatment, and receiving feedback on their decisions when treating such fractures. The phase I activities will include: developing a procedure description, task analysis, functionality matrix, and initial proof of concepts. In addition, we will develop a Likert questionnaire to obtain feedback from subject matter experts, which will rate the benefits and marketability of the simulator as a training tool. Immersion Medical will utilize a general-purpose deep tissue palpation device that will allow users to feel for the pulses and assess for items such as crepitus. Modeled images will be augmented to enable users to visually assess and diagnose femoral fractures and implement appropriate treatment options.

PACIFIC RESEARCH LABORATORIES, INC.
10221 SW 188th Street, PO Box 409
Vashon, WA 98070
Phone:
PI:
Topic#:
(206) 463-5551
Mr. John James
OSD 04-DH1       Selected for Award
Title:Fractured Femur Simulator
Abstract:We propose to determine the scientific, technical, and commercial merit and feasibility of creating a hybrid physical mannequin and PC-based augmented reality training system to teach the diagnosis and treatment of various human femur fractures. It would provide exposure both to common and unusual fracture scenarios to accelerate initial learning and provide exposure to cases that might not otherwise be experienced. The use of a hybrid system allows the development of both cognitive and physical skill through tactile contact with a convincingly realistic leg form with appropriate injuries and through display of photo-realistic imagery, real-time simulated fluoroscopic and x-ray views, and augmented reality images including partially transparent views. The proposed collaboration between Pacific Research Laboratories (PRL) and the CIMIT Simulation Group brings together experience in many of the items covered in the solicitation. PRL is the world leader in orthopedic surgical training models including multiple fracture models and has created custom soft tissue analogs. The CIMIT Simulation Group brings expertise in developing hybrid training systems, including the generation of real-time visual, x-ray and augmented reality imagery, interfacing physical mannequins with PC-based control of active components and instrument tracking systems, and experience in implementing training curricula relevant to theses systems.

SIMULUTION, INC.
16173 Main Avenue
Prior Lake, MN 55372
Phone:
PI:
Topic#:
(603) 898-4657
Dr. Bruce D. Anderson
OSD 04-DH1       Selected for Award
Title:Fractured Femur Simulator
Abstract:Simulution Inc. proposes to work with Melerit Medical AB of Sweden to create a femur fracture simulator to train military and civilian orthopedic surgeons and other medical personnel. The Melerit TraumaVision simulator, a part task, virtual reality simulator, will be modified and already allows surgeons to practice installing internal fixators including screws, pins and hooks into a virtual femur while watching simulated fluoroscopic images. We propose to modify the Melerit TraumaVision simulator to include more functionality and be more realistic. Phase I will demonstrate the feasibility of simulating bleeding and tissue deformation, simulating collisions between instruments and bone, and expanding the simulator to include multiple patient scenarios. The feasibility of including a physical model of a leg containing a femur with many fractures that can be released under computer will be evaluated. The physical model, when developed, will allow physical exam and palpation of pulses. In Phase I a validation assessment of the new functionalities will be done and expanded performance metrics will be defined. The content of an educational CD to be used with the simulator will be outlined. In Phase II a fractured femur simulator incorporating the functionalities developed in Phase I will be prototyped.

TOUCH OF LIFE TECHNOLOGIES
761 Madison
Denver, CO 80206
Phone:
PI:
Topic#:
(303) 724-0514
Dr. Karl D. Reinig
OSD 04-DH1       Awarded: 25MAY04
Title:Fractured Femur Simulator
Abstract:Touch of Life Technologies (ToLTech), in collaboration with the American Academy of Orthopaedic Surgeons (AAOS), the Southwest Research Institute (SwRI), the Center for Human Simulation, and the Orthopaedic Trauma Assocation (OTA), will develop a Fractured Femur Simulator. This simulator will utilize advanced graphic and haptic displays, as well as the data from the Visible Human Male, to portray various patient scenarios with varying complexity of femoral trauma. The simulator will incorporate features such as transparency, fluoroscopy, and simulated ultrasound. Due to their extensive simulation experience and variety of skills, ToLTech is confident in presenting a quality product that will provide realistic force-feedback and visual images in a real-time environment. Tissues will be deformable, polygons can be severed, and realistic lighting models will provide the visualization of blood and other tissues. The deformable models that will be developed for the simulator will also be usable in future simulations of other orthopaedic procedures. With the Fractured Femur Simulator, users will be trained and assessed on their diagnosis, procedural skills, and therapeutic decision-making abilities based on each specific situation. This simulator will be marketed for training and testing of battlefield medics, triage personnel, MASH physicians, and rehabilitative health care professionals.

ALPHATECH, INC.
6 New England Executive Park
Burlington, MA 01803
Phone:
PI:
Topic#:
(858) 812-3173
Mr. Gary Jahns
OSD 04-DH2       Awarded: 03JUN04
Title:Empirical Statistical Estimation of Glucose Concentration Using Thermal Radiation
Abstract:OptiScan Biomedical Corporation's Non-Invasive Glucose Monitor has demonstrated the capability to measure patient blood glucose concentrations using an induced cyclic temperature variation that modulates the natural mid-infrared radiation coming from the patient's tissue just below the surface of the skin. ALPHATECH, Incorporated, can leverage the information extracted by this method using additional signal processing and nonlinear statistical modeling techniques. Glucose concentration affects IR absorption and hence the detected amplitude and phase at the thermal driving frequency. Currently, only the phase information is exploited in the Glucose Monitor. Modeling the signal amplitude and phase within a Support Vector Machine (SVM) framework, an initial simulation shows that the SVM predictive error is a factor of five smaller than that of a linear model. Both the linear and SVM model methods account for confounding variables in the simulation, and offer the potential for estimating the concentrations of other analytes of interest for metabolic monitoring and disease diagnosis. The ALPHATECH-OptiScan team proposes to demonstrate that advanced nonlinear methods are capable of accurately estimating glucose concentration levels in the presence of confounding metabolites in in vitro tests as the first step in the development of a breakthrough noninvasive metabolic monitoring device.

BIOTEX, INC.
8018 El Rio St.
Houston, TX 77054
Phone:
PI:
Topic#:
(713) 741-0111
Dr. Ralph Ballerstadt
OSD 04-DH2       Selected for Award
Title:A Wearable Fluorescence Spectrometer for Transdermal Glucose Monitoring
Abstract:The focus of this research project is to design and evaluate a first-generation prototype of a wearable fluorescence detector and display device for transdermal glucose monitoring. The unique feature of the detector and readout device is its high specificity and selectivity for the glucose metabolite which is provided by a small glucose sensor implanted into the subcutaneous skin regions. The concept of the proposed glucose-sensing concept is one of the most promising technologies currently pursued in glucose-sensor research for its application in diabetes research and therapy. In phase I of this project, we focus on studying the spectral response of the sensor in numerous in vitro situations. After careful analysis we will embark on pursuing to design and package such a wearable device using commercially available optical and off-the shelf electronic components.

GLUCOLIGHT CORP.
115 Research Drive
Bethlehem, PA 18015
Phone:
PI:
Topic#:
(610) 419-6250
Dr. Matthew J. Schurman
OSD 04-DH2       Selected for Award
Title:Optical Coherence Tomography Based Non-invasive Glucose Monitoring
Abstract:Continuous, non-invasive, glucose monitoring has great potential as a tool for guiding insulin treatment in diabetics and in critical care patients. Many optical techniques have been applied to solve this problem, but to date none have achieved the sensitivity, accuracy, or specificity required (which for existing home meters is +/- 15%). Optical Coherence Tomography (OCT) is an emerging technology that has been applied to high depth resolution imaging (~ 10 microns) of tissue. OCT is analogous to a sonogram where back reflected light, rather than sound, is used to form an image. The low coherence of the light used is what gives OCT it's high imaging resolution. We propose to use this technique in a sensing, rather than an imaging mode. In this application, the scattering properties of tissue can be measured with a high degree of accuracy with very tight localization. Since the scattering coefficient of skin tissue varies with glucose level, this technique shows great promise as a continuous, non-invasive glucose monitor.

GLUCOSE SENSING TECHNOLOGIES, LLC
3000 Lexington Court
Export, PA 15632
Phone:
PI:
Topic#:
(412) 624-8875
Dr. Vladimir L. Alexeev
OSD 04-DH2       Selected for Award
Title:Non Invasive Tear Fluid Glucose Sensor Photonic Crystals
Abstract:This Phase I research and development program will develop novel, real-time, noninvasive (or minimally invasive) glucose colorimetric sensors for tear fluid. These sensors are based on new photonic crystal chemical sensing materials recently invented at the University of Pittsburgh. These photonic crystal sensors use arrays of nanoscale particles to diffract light of a color related to the glucose concentration. This glucose sensing material will be the sensing element of a contact lens, as well as an ocular insert designed for placement behind the lower eyelid. The patient will determine glucose concentration by viewing the color of the sensing material in a compact-mirrored device. This colorimetric sensing device contains a white light source, a mirror and a color chart. The observed color reports on the patient's tear fluid glucose concentration. Since the tear fluid glucose concentration tracks the blood glucose concentration, a tear fluid glucose measurement determines the blood glucose concentration. We will optimize the responsivity of these sensor materials and develop fabrication methods to incorporate the sensing material in contact lenses and ocular inset-type devices which can be tested in phase II of this program in animals and humans.

ISENSE DEVELOPMENT CORP.
15055 SW Sequoia Parkway, Suite 170
Portland, OR 97224
Phone:
PI:
Topic#:
(503) 598-0990
Dr. W. K. Ward
OSD 04-DH2       Awarded: 19MAY04
Title:Development of a Highly-Miniaturized Continuous Biosensor for Lactate and Glucose
Abstract:There is a need to develop minimally-invasive devices that will allow continuous and simultaneous measurement of more than one metabolic analyte. Two such analytes are glucose and lactate. The benefits of continuously measuring these analytes in subcutaneous interstitial fluid include early detection of physical exhaustion, for example in firefighters or warfighters, and critical care monitoring of patients with heart failure, respiratory failure or shock. To minimize pain during subcutaneous insertion, the device must be small in diameter. We propose to create a minimally-invasive fine-wire based biosensor whose diameter is no more than 0.35 mm that can be inserted through a 21-23 gauge trocar. The sensor will have two wire electrodes devoted to measurement of lactate and glucose and one electrode that will serve as the common reference. The major challenge will be to enhance the sensitivity of the device to lactate and glucose despite its small electrode area. Techniques that will be utilized to accomplish this goal will include development of sensitive assays for glucose oxidase and lactate oxidase to optimize enzyme loading, optimization of glutaraldehyde crosslinking, optimization of membrane thickness, and etching of the platinum electrode surface in order to enhance amperometric detection and membrane adherence.

LIGHTOUCH MEDICAL
Suite 123, 600 Genessee Street
Syracuse, NY 13202
Phone:
PI:
Topic#:
(315) 478-1670
Dr. Douglas Hagrman
OSD 04-DH2       Awarded: 17MAY04
Title:Noninvasive Metabolic Monitoring
Abstract:Lightouch Medical uses tissue modulated, near infrared Raman spectroscopy to monitor blood glucose and other analytes in human figertips noninvasivey. using this proprietary and completely painless technique, LighTouch is able to measure blood glucose concentrations with accuracy and recision equal to standard fingerstick tests in the entire relevant range of blood glucose levels including 70-110 mg/dl and below. The proposed effort relates to development of an improved tissue modulator.

LYNNTECH, INC.
7607 Eastmark Drive, Suite 102
College Station, TX 77840
Phone:
PI:
Topic#:
(979) 693-0017
Dr. Anjal Sharma
OSD 04-DH2       Selected for Award
Title:Wearable Novel Metabolite Monitor
Abstract:Monitoring of a soldier's health status during deployment will allow for proper countermeasure protocols to be instituted if the soldier becomes fatigued, ill, etc. A variety of metabolic molecules have been identified (e.g., glucose) as markers that can be monitored in soldiers. A monitoring device for these markers would need to be wearable, lightweight, easy-to-use, non-invasive, and non-constricting to a soldier's movement. A few minimally invasive techniques exist today to monitor a single metabolite at a time, particularly glucose; there are none capable of monitoring multiple metabolic markers. Therefore there is a great need for developing a wearable, non-invasive metabolic marker sensor that can monitor multiple analytes at a time. Lynntech proposes to develop a wearable sensor system capable of monitoring multiple metabolic markers at a time from non-invasively extracted interstitial fluid using polymeric optrodes specific to the metabolite of interest. In Phase I, Lynntech will prove the feasibility of the sensor for detection of multiple metabolites, particularly glucose and lactate. In Phase II, Lynntech will build a prototype sensor that fully integrates Lynntech's enhanced extraction technique for interstitial fluid and Lynntech's novel sensor elements into a lightweight, wearable device.

LYNNTECH, INC.
7607 Eastmark Drive, Suite 102
College Station, TX 77840
Phone:
PI:
Topic#:
(979) 693-0017
Dr. Krzysztof Kwiatkowski
OSD 04-DH2       Selected for Award
Title:A New Non-Invasive Continuous Metabolite Monitor
Abstract:Glucose and Lactic Acid are the metabolic markers of choice for health status measurements. Determination of lactic acid threshold in soldiers and athletes during times of extensive muscle use can lead to improved training resulting in higher performance. Intensive monitoring of blood glucose is the most important step diabetics can take to safeguard their health and longevity. In the United States there are an estimated 15.7 million people with diabetes mellitus. Existing methods for monitoring blood glucose levels have limitations. Blood glucose testing is performed only intermittently making it difficult to accurately determine a person's condition. Compliance is often poor due to the discomfort associated with obtaining blood. This proposal concerns a non-invasive method whereby glucose and lactic acid concentrations are monitored using interstitial fluid in a small device that is worn in contact with the skin. The advantages of the proposed device comprise low cost and enhanced sensitivity of the measurements. Phase I will focus on development of microfluidic lactic acid sensor. Upon successful completion of the Phase I effort, Phase II research will focus on addition of microfluidic glucose sensor and interstitial fluid extraction to the lactic acid microfluidic module and testing the device using animal model.

MEDEIKON CORP.
100 Overlook Center, 2nd Floor
Princeton, NJ 08540
Phone:
PI:
Topic#:
(609) 375-2790
Dr. Cristian E. Toma
OSD 04-DH2       Selected for Award
Title:Non-Invasive Glucose Monitoring Using Low-Coherence Interferometry
Abstract:This project proposes a method for non-invasive glucose monitoring based on the analysis of changes in skin light scattering properties induced by changes of glucose levels in skin interstitial fluid. Comparing to other similar approaches, this project proposes a more accurate light-tissue interaction model, based on multiple scattering. The overall goal for Phase I is to demonstrate that the multiple scattering framework has the potential for: a) improved sensitivity and specificity of observables with respect to glucose concentration, and b) improved stability of observables vs. optical skin heterogeneities and specific point of optical contact. Optical probes will be constructed and characterized within the multiple scattering framework. Additionally, Phase I of the project will validate dynamic range improvement using instrument noise and speckle noise filtering algorithms. Phase II of the project will construct an optimized instrument for non-invasive glucose monitoring, based on the results obtained in Phase I.

SPIRE CORP.
One Patriots Park
Bedford, MA 01730
Phone:
PI:
Topic#:
(781) 275-6000
Dr. Kurt J. Linden
OSD 04-DH2       Awarded: 26MAY04
Title:Non-invasive Blood-glucose Monitor using Terahertz Radiation
Abstract:This Phase I SBIR proposal describes a research program to determine feasibility for using terahertz radiation to non-invasively monitor metabolic analytes such as glucose. Non-invasive monitoring is important for determining general physiological activity and health, and needed by diabetics for painless, rapid glucose measurement. Mid-infrared and far-infrared monitoring has been extensively explored, but after many years of research, no reliable instrument is available. Infrared glucose concentration data reliability is poor due to strong radiation scattering and overlapping signals arising from blood components that maski glucose signals. Based on published data, improved molecular discrimination may occur in the terahertz spectral region, where DNA and organic-molecule resonant absorption spectra dominate, where photon scattering is reduced, and where a new generation of miniature cascade-lasers is under development. Phase I will investigate terahertz absorption spectra in glucose-containing phantoms simulating blood, and in purchased laboratory blood solutions with known glucose concentrations. The measurements will be performed at the Brookhaven synchrotron source, using an FTIR spectrometer and terahertz radiation detector. The proposed project dovetails with a companion program to develop a miniature terahertz cascade-laser source at Spire Biomedical. Phase II will include tissue-measurements and develop a portable, non-invasive monitoring system using the terahertz cascade-laser.

CYBERNET SYSTEMS CORP.
727 Airport Boulevard
Ann Arbor, MI 48108
Phone:
PI:
Topic#:
(734) 668-2567
Dr. Charles J. Jacobus
OSD 04-DH4       Awarded: 15JUN04
Title:NIRS for Deep Brain Tissue Oxygenation Measurement
Abstract:A noninvasive physiological monitoring device capable of monitoring from multiple sites to determine surface and deep tissue oxygenation in real time will benefit virtually all areas of the medical community. This tool will be invaluable for the entire medical arena, offering a cost effective method of vastly improving patient care. The specific use solicited it to penetrate through the skull and detect/image blood beneath the skull surface and in the cortical layer of the brain. The goal is to make a low cost portable device that can diagnose traumatic brain injuries in operational environments (acute subdural hematoma, SDH). This will be done by applying NIRS or Near Infrared Reflective Spectroscopy technology to this problem leading in Phase I to a feasible system concept and in Phase II to a proof of concept prototype instrument. Cybernet is qualified under FDA Good Manufacturing Practices to design and manufacture medical instruments and has several low cost medical products in production at the present time.

ELECTRICAL GEODESICS, INC.
1600 Millrace Drive, Suite 307
Eugene, OR 97403
Phone:
PI:
Topic#:
(941) 687-7962
Dr. Don M. Tucker
OSD 04-DH4       Awarded: 15JUN04
Title:Near-infrared Optical Biosensor Brain Injury Evaluation
Abstract:Near-infrared light (NIR) can detect intracranial hematomas with good sensitivity and specificity. However, commercial systems have not proved clinically useful. Early detection of hematomas is important for emergency head injury evaluation. The resulting pressure can cause significant brain damage or death, yet the pressure can be relieved if detected. We propose to create a portable NIR system that is accurate without MRI or CT imaging. It will provide detection before symptoms of intracranial pressure are severe. It will be quick, easy to use and reliable with minimal training. It will be inexpensive enough to find widespread civilian and military use. We begin with a design for an optimal device for rapid, effective diagnosis in the civilian emergency department and the military field or ship hospital. We identify the technical problems that must be solved in order to achieve this optimal device and procedure. We then demonstrate the feasibility of solving the key problems, drawing on several proprietary advances based on our DARPA NIR project. Finally, based on our experience with dense array EEG in emergency medicine, we design a clinical trial for Phase II that will validate both statistical and clinical significance of the Near-infrared Optical Biosensor Brain Injury Evaluation (NOBBIE) technology.

GEOPHEX LTD.
605 Mercury Street
Raleigh, NC 27603
Phone:
PI:
Topic#:
(919) 839-8515
Dr. Stephen J. Norton
OSD 04-DH4       Awarded: 15JUN04
Title:Portable Near Infrared Technology for Detection of Traumatic Brain Injuries in Operational Environments
Abstract:Acute head trauma can cause disability and death without prompt diagnosis and treatment. The methods of choice for such diagnosis are x-ray CT or MRI, but these systems are costly and lack portability. Blood has an electrical conductivity and a dielectric permittivity about 50 to 100% higher than that of healthy brain tissue, depending on the excitation frequency. This suggests that an entirely non-contact technique for detecting bleeding in the brain (hematoma) could be based on a magnetic induction measurement that responds to anomalous changes in the conductivity between the skull and dura. One possible design of such a sensor would consist of concentric transmitting and receiving coils in close proximity to the head, but not touching. If the frequency is swept over a suitable range, then a one-dimensional profile of conductivity as a function of depth could be generated by exploiting the electromagnetic skin effect. The advantages of this approach over near-infrared spectroscopy include the non-contact nature of the measurement and the possibility of using a conductivity profile to delineate the dimensions of the hematoma. A conductivity sensor could be designed to be portable, compact and relatively inexpensive. A prototype sensor suitable for testing on tissue phantoms will be developed in Phase I.

NIM, INC.
3401 Market st. Suite 140
Philadelphia, PA 19104
Phone:
PI:
Topic#:
(215) 387-6784
Dr. Baruh B. Dor
OSD 04-DH4       Awarded: 15JUN04
Title:Portable Near Infrared Technology for Detection of Traumatic Brain Injuries in Operational Environments
Abstract:In the battlefield setting, it is necessary to triage patients with severe injuries. With both open and closed head injuries, the most important factor determining whether or not a patient requires emergency surgery, is the presence of an intracranial mass lesion. CT scanning is the gold standard for identification and localization of traumatic intracranial hematomas. In the battlefield as well in rural areas of the US and in underdeveloped areas of the world, CTs are not available. Near infrared (NIR) may be a practical solution because of the unique light-absorbing properties of hemoglobin. In pilot studies conducted at Baylor College of Medicine by Dr. Claudia Robertson and Dr. Shankar Gopinath using the RunManT NIR monitor, sensitivity for extracerebral (epidural and subdural) hematomas was 100% and sensitivity for intracerebral hematomas was 98%. There were no false positives. The pilot data demonstrates that the detection of presence of any type of hematoma is feasible with NIR. The main objective of this study is to develop a NIR monitor specifically designed to detect the presence of an intracranial hematoma in the field setting. The goal of this Phase I plan is to determine the optimal configuration and parameters of a clinical system (Hematoscope).

PHYSICAL OPTICS CORP.
Photonic Sys Div, 20600 Gramercy Place, Bldg 100
Torrance, CA 90501
Phone:
PI:
Topic#:
(310) 320-3088
Dr. Paul Shnitser
OSD 04-DH4       Awarded: 15JUN04
Title:Intracranial Hematoma Detector
Abstract:Small field hospitals in operational environments lack MRI and CAT scan equipment, making it difficult to diagnose closed-head injuries. To address the military need for a portable device to detect traumatic brain injuries, Physical Optics Corporation (POC) proposes to develop a new Intracranial Hematoma Detector (IHD) based on continuous wave NIR spectroscopy. The IHD is a battery-powered, compact hand-held device. Within seconds, it measures light "transmission" in multiple directions around the observation point on the patient's head with high sensitivity and dynamic range. Applying the IHD at several points and comparing the light transmission from multiple directions will enable the operator to locate any area of increased light absorption by blood compared to the rest of the head. In Phase I, POC will demonstrate the feasibility of the IHD design concept and demonstrate its performance on a hematoma model. In Phase II, POC plans to develop a full scale IHD prototype and conduct animal testing.