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These prototypes will be evaluated by occupational hygiene professionals to assess their usability and suitability for impulse noise monitoring. Prototypes at this stage should be usable during military training operations by personnel who do not have specific expertise in impulse noise exposure. In addition to the 10 prototypes, the contractor will provide advanced software which generates a report that includes the following risk analyses, in accordance with requirements laid out in MIL-STDE.

The report should include Phase I d and,. AHAAH unwarned the warned reflex has been widely repudiated as not reliably protective ;. LAeq 8 Hr; and,. LAeq ms.

This software should be evaluated by occupational hygienists and safety personnel without impulse noise measurement experience, and will be judged based on user friendliness in downloading, reviewing, and organizing the resulting data. Both the Army and Navy Public Health Centers have requirements to monitor occupational noise exposure and have hearing conservation programs that focus on noise hazard identification, hearing protection, and monitoring audiometry.

Thus, these intermediate-level impulse noise dosimeters and its associated software systems would be well suited for Government use. These Public Health Centers, as well as installation safety and occupational hygienists, are examples of potential government customers that are interested in acquiring this type of technology. Additional customers for these products may include police departments to monitor for noise exposure during firearms training, and other occupational hygienists and safety professionals which monitor processes with impact or impulse noise such as mining, hammer forging in manufacturing sector, and jackhammering and pneumatic nail gun use the construction industry as examples.

There is a likelihood that these issues could be further complicated due the new requirement of Maneuverability Center of Excellence to develop lighter weight personnel protective equipment to meet the demands of the Warfighter in future multi-domain operations MDO. Pratt NJ. Potentially injurious mechanical forces of blast include, but are not limited to, overpressure, accelerative forces, and impact forces on the subject from dislodging.

Blast overpressure is in the order of nanoseconds for initial peak rise time with a total event time-scale less than milliseconds for improvised explosive device IED. This is a near instantaneous environmental exposures, thus any innovative technology should quickly respond to mitigate injury. GPS or communication equipment carried by the Warfighter. A demonstration will be achieved by subjecting the prototypes to dynamic loading of blast overpressure exposure at different pressures e.

Blast and animal research capabilities at WRAIR may be leveraged to test the efficacy of the prototype. Consideration should be given to large animal models for prototype testing that may include pig, sheep, or non-human primates. Prototype should not significantly burden the soldier with weight and should be comfortable to wear. Prototype should be easy to use and operate.

In addition, it should not interfere with any communication system used by the Warfighter. The technology should demonstrate protective-ness against blast related traumatic injury under the testing conditions in the laboratory.

The prototype effectiveness can be shown through the assessment of injury reduction e. At the end of this phase, the prototype should demonstrate a clear path to show efficacy in pre-clinical testing and future readiness for testing in scaled human conditions to show the protectiveness of the product.

Development of the underwater blast lung model will improve existing injury predictions and provide actionable injury assessment to mission planners as they evaluate operational risk management. The Department of Defense DoD has sponsored the development of computational models that predict how the human body will respond to in-air blast insult.

The focus of this SBIR is to identify a software modeling approach that can characterize the physiological response of human lungs to underwater blast insult. The model must be able to compensate for the lungs being under hydrostatic pressure up to ft seawater for divers operating on scuba equipment.

In addition, the interactions between the blast wave and lung response with the surrounding bone, muscle, and tissue in and around the thoracic cavity needs to be incorporated into the model. As divers may be using different gas mixes other than air e. This model will provide predictive physiological responses to underwater blast to improve risk modeling for establishing safe standoff distances for EOD divers working around explosives.

The software models developed by this SBIR can be marketed for use by the DoD and other communities, who have divers working with explosives or other impulsive noise sources e. Early adopters of the software modeling products from this SBIR may include surface and undersea warfare operators and undersea construction and salvage crews.

In addition, these models would also be valuable to environmental protection groups within the DoD as well as industry for use in predicting injury to marine mammals and other aquatic life. Companies have had success being able to commercialize high fidelity human anatomy models for the scientific community. PHASE I: In Phase I, researchers will identify the physical modelling requirements and physics that must be solved related to the properties of the model.

Researchers will identify an appropriate code base that is suitable for solving the response physics. A simple model e. Model outputs shall be validated against theoretical predictions or experimental data. The physiological variables that will need to be incorporated into the model to transition from the simple spherical model to an anatomically correct version of the model shall be characterized.

The performance and capabilities of the final model for Phase I will be demonstrated. Finally, researchers will identify the recommended approaches that will be used in Phase II. These approaches will be identified in consultation with the COR and subject matter experts. PHASE II: In Phase II, the model will be made more complex by transitioning to an anatomically-correct lung shape and incorporating specific tissue and material properties of the lungs and surrounding tissues.

Specifically, an upper torso model shall be created that incorporates bone, soft tissue, lungs, and diaphragm at sizes accurate to a 50th percentile male. The model outputs shall be compared to experimental data from physical models to be provided by the COR. Each of the tissue layers should show a response to the underwater blast insult. However, the interactions between tissues, being much more complex can be planned for Phase III.

This will include high fidelity anatomical structures as well as the interactions between all structures e. The model should be able to respond to a variety of UNDEX scenarios including explosives with different charge weight, explosive type, and location of explosive relative to lungs in water column. Also, the model should incorporate lungs at different depths and orientations in water column, as well as with the lungs at different inflation volumes e.

The Completed model and data will be delivered to the sponsor for further evaluation and analysis. Additional Phase III follow-on work may include extending the modeling techniques to marine mammals or diving birds.

This model will provide immediate value for DoD entities such as Naval Surface Warfare Center Indian Head and the Naval Submarine Medical Research Laboratory, who support the development of safe standoff requirements for divers operating around underwater explosives.

Additional non-DoD customers that this model could be marketed to would be industries that employ divers for explosive work, construction, and other infrastructures in which divers are subjected to high energy underwater sources such as explosives, pile driving, or seismics. Numerous companies have developed high fidelity human models that are available for commercial use e.

Zygote, Biodigital, 3D4Medical. There is a strong potential of interest from academia and scientific institutes for evaluating effects on animal models i. OBJECTIVE: Demonstrate technology for automatic association of environmental conditions and activities with chemical and physical exposures based on feedback from body worn and area monitors to augment health risk assessments.

In a traditional occupational environment, an industrial hygienist or technician manually observes and logs events and work activities that are associated with exposure levels of concern. By automating the identification of activity and environmental conditions using feedback from body worn and area sensor systems and leveraging the internet-of things, the industrial hygienist can more readily provide specific feedback to workers to mitigate potentially hazardous exposure conditions.

Activity data of interest include specific information about operational tasks, including operation of specific machinery in a maintenance shop, or various actions associated with flight line maintenance, such as pre-flight checks and refueling actions. Environmental data of interest include information such as indoors versus outdoors, local ventilation conditions and weather.

The algorithm and integration hardware should be designed to incorporate data from commercial off-the-shelf sensors, such as MultiRAE gas monitors present at most military bases , standard noise dosimeters, weather monitors, smart wearable technologies e.

The final algorithm and associated integration hardware must store logged data locally, incorporate a user-interface, and operate for at least 10 hours on battery power. The device will also incorporate user-configurable alarm settings and an option for the user to provide feedback to the device regarding notable activities. The data should be exportable in formats compatible with DoD environmental and biomonitoring programs.

PHASE I: During the phase I effort, a prototype system will be developed to demonstrate the technical feasibility for an algorithm and interface for context-sensitive environmental monitoring.

The algorithm and associated integration hardware will be demonstrated for its ability to automatically identify maintenance-related tasks, such as painting, stripping, and sanding, completed in a controlled environment e. An interface will be designed where the worker being monitored can provide feedback to train the algorithm and contextual information can be provided back to worker. PHASE II: During the phase II effort, a robust system will be demonstrated that is capable of automatically and accurately identifying specific work tasks, such as welding, drilling, sanding, stripping, and painting, as well as basic environmental conditions, in a military field environment.

The government will provide parameters for metadata needed. The th Human Performance Wing will test the prototype independently during this effort and provide feedback back to the small business in order to accelerate the development of a product that is practical to transition to an operational environment.

In addition to providing value to the DoD, context-sensitive technology capable of automatically associating environmental conditions and activities with chemical and physical exposures would be valuable to industrial hygienists working in construction, manufacturing, and maintenance industries where workplace exposures require consistent monitoring to ensure health and safety of workers. The final product will be relevant for research applications where activities and locations linked with exposure levels could be associated with epigenetic markers or chronic health outcomes, such as noise-induced hearing loss, heart disease, and cancer.

Determinants of RF weapon antipersonnel effects are multifactorial and RF injuries will be situation dependent and very hard to predict. Without known patterns of RF injury to guide diagnosis, it will be difficult to differentiate RF injury from other common sources of illness and injury such as heat stroke.

This ambiguous symptomology is aggravated by the transient nature of RF energy. Without a sensor it is possible that no residual evidence of RF attack will be available. A wearable RF detector to signal and document exposure to injurious levels of RF energy will allow personnel to take timely and appropriate protective measures, enable confident diagnoses of RF exposure injury, and serve as a critical intelligence resource for defining current battlefield threats.

However, to be useful, the wearable RF weapon exposure detector must, in order of importance, have an extremely small footprint in terms of space, weight and power SWaP , be very low cost, have a very low false positive rate, and be easy to interpret.

The topic does not seek a replacement for sophisticated instruments used for measuring occupational hazards. This RF detector concept is analogous to passive M8 and M9 paper used in the detection of chemical weapon hazards.

Determine optimal detector threshold sensitivity for signaling immediately dangerous to life and health IDLH exposure while minimizing false positives. Because irradiance levels needed to injure personnel are orders of magnitude higher than required to damage electronics, designing a broad band absorber with appropriate response characteristic will require substantial innovation.

Design a low cost, low SWaP, low false positive, easily readable, wearable RF weapon exposure detector that can widely distributed on the battlefield. High cost, high complexity sensors are not desired for this solicitation. Model expected system performance from component testing. Review non-open source information regarding military RF systems and RF bioeffects provided by government.

Refine design and build production representative prototypes and validate detection performance in laboratory environment. Provide prototypes for operational utility evaluations. Conduct environmental testing. Desired end state would be to establish the Wearable RF Weapon Detector as a standard military equipment supply item distributed through Defense Logistics Agency.

Additional commercial applications include medical, industrial, manufacturing, and test facilities in which personnel may be inadvertently exposed to high power RF sources. OBJECTIVE: Develop a portable, customizable, computerized dynamic balance and measurement system that allows programmable levels of instability to deliver accurate Sensory Organization Tests in clinic, home, or field environments.

TBI and MSKI both cause short-term disability, but can have lasting consequences such as loss of strength and motor control, chronic pain, cognitive deficits, and permanent neurological damage. Balance training is used to improve postural stability after injury and must target all three systems for optimal effectiveness. Currently, the most common form of balance testing and training in clinics uses a balance board or stability ball to create an unstable surface to train the somatosensory system.

More recent efforts have engaged the visual system by integrating virtual reality VR with static force measurement platforms to assess COM motion in various VR environments.

While integrated VR systems have expanded the types of visual and vestibular perturbations available, use of a static force platform means the motor control system is not challenged or perturbed in a controlled manor. Systems with dynamic platforms would be beneficial for assessment and rehabilitation from vestibular and musculoskeletal injuries. More traditional balance testing systems incorporate programmable moving platforms capable of perturbing and measuring COM movement e.

Their ability to concurrently or independently manipulate the visual, vestibular, and somatosensory systems make them an invaluable tool for delivering an objective Sensory Organization Test SOT , which can help the clinician to determine if therapy is needed and which sensory system to focus on. Indeed, a large amount of normative and clinical SOT data exists for military personnel across various branches5.

Though considered the gold standard for vestibular physical therapy assessments, the utility of current CDP systems are undermined because of their large size, high cost, and limited functionality i. The goal of this SBIR is to develop a product that maintains the strengths of traditional CDP systems, but that takes advantage of the developments in portable balance measurement devices and portable display technology e.

VR , thereby creating a lower cost and portable balance assessment and training system. Currently, there are no commercially available portable platforms that combine COM measurements with computerized dynamic control of platform stability; these are essential for conducting SOTs and targeted training.

The development of such a platform in conjunction with VR, or similar technology, can be used to not only provide balance perturbations seen in SOTs i. The purpose of this SBIR is to create a portable, computerized dynamic balance and measurement system. The mechanism e. Although no defined standards need to be met for the following aspects of the system, specifications such as platform translation, and the number and increment of instability levels should be pre-determined by the performer.

To be effective, the device should be able to:. Unity , for integration within custom gaming applications. An initial proof-of-concept design will be developed to demonstrate that the product is able to meet minimum functional capability. The technology should be designed for use, at minimum, in a research or clinical setting i. Additionally, the dynamic response of the proposed device should be mathematically outlined and numerically simulated, showing the limits and expected response of the device in terms of user mass, platform acceleration, and deflection angle.

A working prototype of the physical design is preferred to demonstrate eventual full system capabilities. Together, Phase I deliverables include:. The performer must validate the accuracy and precision of COM measurements, tilt angles, and instability levels under varying conditions e.

As such, the performer will demonstrate that the system is portable and can be used in a variety of settings, while providing accurate measurements. An initial FDA regulatory plan should be provided if applicable.

Finally, in Phase II, the performer will also develop the software that accompanies the physical device. The software should be capable of defining and controlling tilt angles and instability levels. It should also provide real-time visualization of COM movement and platform tilt angles. An application should also be designed that will deliver the SOT, collect accurate COM information, and provide composite measurement results as well as individual scores for each of the SOT conditions.

Phase II deliverables include:. The physical working prototype balance platform capable of varying levels of tilt and instability. Instruction manual for setup and usage. Accompanying software that allows the user to connect a computer wired or wirelessly for data streaming and visualization. Specifications document that details limitations of the device e. Application that delivers the SOT and provides composite and individual condition scores.

This will support future commercialization efforts in both military and civilian markets. Key customers may include facilities that currently own CDP systems, including large military treatment facilities e. Palo Alto, Minneapolis, Seattle , and academic universities e. Additionally, a portable and lower-cost system would enable medical facilities to purchase and use more than one balance system in different clinics.

It would also enable access to objective assessment and rehabilitation tools at military clinics e. Twentynine Palms and civilian outpatient clinics. A successful device could also have implications for use in deployed settings if ruggedized. Commercial markets that could benefit from this novel product would include: private rehabilitation centers, sports training centers, and research organizations.

In concert with resuscitative intervention and supportive care, MCMs would improve survival and reduce recovery times for the individual contributing to a higher level of unit readiness. The Joint Force must effectively protect the maximum number of personnel against the greatest number of hazards as far forward as possible, and sustain the casualty from the point of exposure to the point of definitive care. These MCMs will be administered at the lowest echelon of health care possible.

They will work in concert with other medical products to lessen performance degradation and increase survival for the individual contributing to a higher level of unit readiness. To be effective, any prophylaxes must be available to Joint Force personnel prior to ionizing radiation IR exposure. It will reduce the likelihood of developing severe adverse health effects associated with ARS to increase survival.

Prophylaxes would be administered to the Joint Force prior to operating in a known, high risk Ionizing Radiation IR environment. ARS encompasses a spectrum of pathophysiologic changes caused by exposure to high doses of penetrating radiation in a relatively short time period. Injuries sustained depend on the dose and extent of radiation exposure e.

Radiation exposures exceeding 2 Gray Gy in adults can result in the depletion of hematopoietic stem cells and cellular progenitors in the bone marrow, which may lead to severe neutropenia, thrombocytopenia, and death from infection or hemorrhage.

Higher radiation doses can cause gastrointestinal GI complications, including mucosal barrier breakdown, bacterial translocation, and loss of GI structural integrity, which can lead to rapid death. Individuals who survive ARS may suffer from the delayed effects of acute radiation exposure DEARE , which can include pulmonary, renal, cardiovascular, immunological, and cutaneous complications occurring weeks to months after radiation exposure.

Future pharmaceuticals will be used in concert with the most appropriate and cost effective mix of existing protocols for treating radiation injuries and could be used at any role of care. Together, future pharmaceuticals and existing medical management protocols e.

The objective of a prophylactic MCM is to reduce the likelihood of developing severe adverse health effects associated with ARS to increase survival. The prophylactic MCM must work in concert with other medical products to lessen performance degradation and increase survival for an individual contributing to a higher level of unit readiness.

A prophylactic MCM will need to be given pre-exposure, pre-symptomatic and be administered at the lowest echelon of heath care possible to the Joint Force age range of 18 - 62 years prior to operating in a known, high risk irradiated environment. To achieve this effect the method of administration must be tailored to optimize ease of administration in an operational environment. Demonstration of efficacy in some form of an in vivo model is also acceptable, but not required for Phase I.

Technologies of interest include, but are not limited to, drugs, but can include biologics or cellular therapies. Information garnered from Phase I experiments may be more qualitative than quantitative. In these studies, the MCM would be administered to animals prior to radiation exposure. The animal model should be of sufficient size and scope to demonstrate a statistically significant increase in survival in animals receiving the MCM.

Optimized formulation studies involving development of a preparation of the drug should be conducted during this phase II effort. A second means for demonstrating success is the establishment of funding and partnering with commercial companies if necessary to facilitate bringing the product to market, as resulting products may be applicable to various medical e. In the best medical evacuation systems spanning the past 18 years of conflict in Iraq and Afghanistan, U.

Wound infections can develop days following injury and are largely attributed to Gram-negative organisms acquired in the hospital setting 1. Pseudomonas aeruginosa is one of the most frequent causes of wound infections and can result in significant morbidity and mortality.

A surveillance summary of P. Moreover, in the present coronavirus disease COVID era, patients on mechanical ventilation due to the disease can become coinfected with hospital-acquired P.

Given the morbidity and mortality rates associated with drug-resistant infections of P. The desired Fishing Boats For Sale Under 10000 Series product will have efficacy against clinically-relevant, MDR strains of P.

The product will demonstrate effectiveness in in vivo bacterial infection models e. Activity against P. Prototype compounds may include small molecules, peptidomimetics both up to MW , or peptides up to MW We will not accept proposals for antibody, bacteriophage, nor vaccine solutions.

The awardee should be able to demonstrate that the selected molecules perform similarly or better in vitro to current standard of care antibiotics in the treatment of MDR P. Required Phase I deliverables will include 1 a practical chemical synthesis of small molecule antibiotic candidate compounds amenable to scale-up; 2 demonstration of in vitro efficacy against military-relevant, MDR strains of Pseudomonas aeruginosa to include minimum inhibitory concentrations MICs ; and 3 assessment of in vitro toxicity in relevant cell lines.

A viable commercial technology transfer partner would be required to complete the full FDA-approval process. Potential commercial applications for this product include analogous applications, as mentioned above, in public, medical treatment facilities, as well as potential Gram-negative biothreat indications.

The device will be designed to operate effectively in a deployed setting that will include static, dismounted medical units as well as medical transport vehicles ground and rotary-wing ambulances.

Specific emphasis will be placed on portability, reliability, and design for the particular challenges of the battlefield environment to include no- or low-light, loud or noise-discipline conditions, cramped space, extreme temperature environments, elevation, etc. While the size, weight, power, and performance constraints will not be as rigid for a Phase I prototype, the ultimate goals for Phase II should be considered and attainable.

Long-term need for stacking capability will be considered. Though water has been shown a viable feedstock for oxygen generation, water of adequate purity is a logistical constraint in the prolonged field care environment.

However, possible alternative non-liquid feedstocks to transiently supplement the fundamental oxygen delivery capacity of the device are not excluded nor required any hazardous byproducts must be mitigated. An argument for the approach chosen, to include recognized open questions in the literature, will be included.

PHASE II: This phase will consist of further development of a portable oxygen generating device demonstrating its utility, and validating the prototype s through relevant testing.

The second year will involve refinement and more rigorous testing of the chosen design in contractor-arranged laboratory studies to determine purity of the oxygen produced and accuracy of flow rates. The contractor would ideally identify appropriate potential commercialization partners manufacturing, marketing, etc. The device will be functional for use by medics, physician assistants, nurses, and physicians in far forward environments roles of care and ambulances.

Phase III will also include developing and finalizing training methods and protocols for the new device. In addition, the regulatory package should be in its final form ready for submission to the FDA, including all relevant test data.

Despite advances in non-vaccine prevention, the US military experiences a steady epidemic of approximately new HIV infection every year. The US Military HIV research program MHRP is engaged in collaborative research with multiple academic, corporate, and governmental partnerships to develop and test immunologic approaches to prevention and therapy. Monoclonal antibodies have great potential for use in prevention and treatment for many infectious diseases including HIV.

However, current approaches to monoclonal antibody delivery are limited by price and durability of effect. MHRP seeks to develop innovative ways by which broadly neutralizing monoclonal antibodies mAbs can be delivered to overcome these challenges. Delivery of gene encoded mAbs by electroporation EP is a potential approach. EP has been used in basic research for the past 25 years to aid in the transfer of DNA into cells in vitro.

EP in vivo enhances transfer of DNA vaccines and therapeutic plasmids to the skin, muscle, tumors, and other tissues resulting in high levels of expression.

EP delivery of vaccines has been demonstrated to induce immune responses in numerous pre-clinical animal models and in human clinical trials for many different infectious diseases and cancer. Delivery of gene-encoded antibodies differs from these active vaccination approaches in that it seeks to minimize immune response to mAb delivery. The method of delivery by using EP technologies and a device capable of delivering selected mAbs will be the desired end product for this effort.

Research could be built upon similar existing technology for other products such as DNA vaccines and therapeutic plasmids. Phase I will focus on technology conceptualization of DNA-encoded mAbs including performance parameters. The performer will develop rapid methods of delivery of DNA-encoded mAbs.

These methods may include the administration of DNA via an intramuscular injection followed by very short electrical pulses electroporation or EP that enable the efficient uptake of the DNA by the muscle cells, leading to much higher levels of expression of the delivered genes than with an injection alone.

MAb-encoding DNA should be delivered in a way that minimizes tissue perturbation, avoiding any immune responses and enabling stable, long-term gene expression.

Upon completion of Phase I the awardee will have developed, demonstrated and validated the delivery method for DNA-encoded mAbs. PHASE II: After successful completion of the Phase I, the awardee will focus on finalizing and refining delivery method and use the results from Phase I studies to optimize the capability of gene encoded mAb technology in small and large animal models. Phase II efforts will focus on developing methods for manufacture of the delivery device for clinical use.

Further the studies should be conducted to demonstrate proof-of-concept that therapeutically relevant serum mAb levels can be achieved in animal models with large blood volumes using human-sized prototype of EP devices.

The prototype specifications will be defined based on feedback from large animal data to meet the requirements of the delivery system in humans. An initial FDA regulatory plan should be submitted at this stage if appropriate to the product development effort.

Upon completion of Phase II of this project, the awardee will be able:. Conduct life cycle and environmental testing with the prototype. The performer will provide data package plan required for application to the FDA after successful large field testing of the assay prototype. A potential method of transition for this product will be through the Army futures command following the decision gate process which includes a technology transfer agreement with U.

In addition, civilian commercialization of this product is likely to include GLP production and GMP manufacture and distribution. This need is not limited to theaters of war; maintaining blood bank inventories around the globe is critical, but as biologics, these products must be transported with proper cold chain maintenance in containers that can withstand arduous journeys and austere environments and can minimize breakage of storage bags for peak logistical efficiency.

There are multiple points of potential failure: for instance, after a donation at a blood drive, blood must be packaged and transported to the blood bank where it is required to be tested, processed, and stored until laboratory results are obtained. Then, the blood must be inventoried, packaged, and sent to distribution.

It must be maintained cold during shipment overseas potentially with multiple stops before receipt and storage at local facilities. Additionally, it must be maintained cold for in-country ground and air shipping to Role of Care 2 or 3 facilities see [12] for descriptions of Army Roles of Care , at which it must be stored until used or until packaged for carrying by a medic prior to a high risk mission Role of Care 1.

At each step, temperature control is critical if blood is to remain in compliance with established standards; very little variance is allowed. Thus, along with the capability of maintaining these temperatures, a careful record demonstrating the unbroken cold chain is required.

Development of a standardized low- or no-power advanced transportation container or container system for blood and blood products that will maintain the cold chain with confirmation and minimize breakage and waste is of critical importance.

Specific emphasis should be placed on the following parameters: scalability for different Roles of Care, minimizing weight for each step of the transport process; stackability for usage on military aircraft; ruggedness and reusability justified by the relative cost; integrating or easily used temperature monitoring; size appropriate for required capacity e.

The device will be designed such that usage can be standardized across a variety of environmental factors. Specific emphasis will be placed on weight, stackability, ruggedness, temperature monitoring capability, capacity, power requirements, potential integration into vehicles including unmanned aerial systems, and cost. An argument for the approach chosen will be included.

PHASE II: This phase will consist of further developing the low- or no-power advanced transportation container or container system for blood and blood products, demonstrating its utility, and validating the prototype s through relevant testing.

The second year will involve refinement and more rigorous testing of the chosen designs in simulated field tests. Phase III will consist of finalizing the device design s and delivering manufactured devices in their final form for military-relevant testing e. The device will be functional for use by blood bank personnel, logisticians, medics, physician assistants, nurses, and physicians in far forward environments roles 1 and 2 of care.

Phase III will also include developing and finalizing training methods and protocols for the new device s.

In addition, the regulatory package should be ready for submission to the FDA, including all relevant test data. The contractor should begin establishing relationships with appropriate commercialization partners manufacturing, marketing, etc. The acquired images are to be displayed in real- time using a handheld screen, archived and accessible for reviewing on demand in retrospective analyses.

US is able to show location and movement of internal organs and blood flow through vessels in the human body by using the amplitudes and travel times of the received reflected sound waves that are reconstructed into an image. Laser Ultrasound LUS employs a completely different signal acquisition technology, with advantages for the battlefield, compared to conventional US. LUS uses the light of two low powered lasers transmitted through air to measure acoustic vibrations.

It supports rapid use as it only needs to be moved above the patient, with no connecting medium required, no physical contact. This is advantageous in cases where skin contact is prohibited due to burns or, e. In contrast, conventional US requires contact of a probe with the patient surface accompanied by a contact medium.

Zhang et. The optical source for the reported LUS system minimizes tissue penetration, specifically to convert optical energy to acoustic energy at the tissue surface. LUS uses very low power laser light and does not use ionizing radiation, so it is very safe, and safe for eyes. With an appropriate optical design and interferometry, any exposed tissue surfaces can become viable acoustic sources and detectors.

Employing skin surface photoacoustic sources in combination with laser interferometric detection i. This project involves redesigning the ncLUS to have a compact, lightweight, portable format; a shirt- pocket-size handheld imaging scanner similar in size to a cellular phone, with visualization via a wired or wireless handheld screen. The back of the device would contain the scanning lasers.

Sides of the device would have connected components, either hinged to flip down, or telescoping. These would assist operating the ncLUS to stand off the body surface as it is moved over the body surface.

This project will necessitate innovative engineering. In this physical format, ncLUS can become a powerful asset to evaluate trauma and plan optimal treatment in cases of internal injury. Secondly, the ncLUS can provide a useful training device [2]. US, of all medical imaging modalities, has favorable use advantages which include: its reliance on non-ionizing radiation; its real-time cine imaging capability; and, its ability to be built into portable systems having simple power needs e.

US trauma imaging includes several standard US examination techniques: Focused assessment with sonography for trauma FAST examination - to screen for blood around the heart or abdominal organs; and, extended FAST eFAST - to detect pneumothorax, hemothorax, pleural effusion, or a foreign object.

Military use [4] of portable conventional US i. Initially, to prove feasibility, a physical, electronics, optical and circuit design of the final handheld ncLUS product should be completed as the first deliverable. The electronic and circuit designs should include commercially available electronic, computer and optical components, or components that can be fabricated easily and without extraordinary expense.

The physical design of the ncLUS must have a form factor of approximately the width and height of a cell-phone, but may be slightly thicker.

It should fit in a shirt breast pocket. Weight should be minimized. The physical design should also include fold-out sides or similar simple, easy to manipulate mechanism in order to provide the key separation between the handheld ncLUS and the body of the subject being scanned.

The ncLUS should be designed to operate by battery for a minimum of one hour prior to battery recharging. The scanning device should contain an Android computer capable of performing the computations that reconstruct an image in near-real-time, i.

This computer should also be able to transmit the images wirelessly or by wire to an external device for display, or use the native screen. Storage of images for replay and archiving should be accomplished using the device, and perhaps an external computer.

Innovation is encouraged in each design aspect to create a lighter, more rugged, longer charged device. A second deliverable is a CAD computer model of the scanner, accompanied by a physical mock-up of the scanning device. A third deliverable is a description of the image acquisition and reconstruction methodology. This is necessary because of the innovative role of lasers in signal acquisition.

A detailed software schematic must be produced to indicate the real- time computational path leading from the acquired laser signals as they are converted to greyscale image, and as the image is displayed. Specific existing software, or a plan to program new software, must be identified that can accomplish each step involved in the software path.

PHASE II: The overall objective of Phase II is to produce a fully operational prototype handheld ncLUS scanner in the specified form factor that can acquire human images in tests, archive and display the images on external devices, retrieve the images from the archive and redisplay them.

The first goal of Phase II is to produce prototype hardware based on the electronics and optical design of Phase I. The emphasis should be focused on hardware integration and operation during this stage. This task will produce the first deliverable, a 2x or 4x size prototype of the ncLUS that acquires laser signals that can be observed on an oscilloscope.

The prototype should initially adhere to the Phase I design except for its physical size. Testing of improvements and changes is then encouraged in order to take advantage of the state-of-the-art in electronics, computers, and optics.

The signals should be acquired from an inanimate phantom at this early stage. The next aim is to expand the emphasis to the programming and testing of software for the scanner. The aim of this stage is to produce a second deliverable that is a modified form of the first deliverable, except replete with fully operational software for the acquisition of laser signals, reconstruction of the greyscale images, and transmission of the images to an external handheld computer.

Innovation in the transmission, storage and display of images is encouraged. This system and software should be tested extensively with inanimate phantoms. Power deposition must be demonstrated to not exceed FDA guidelines. Next, the focus should shift to the production of a fully functional prototype ncLUS scanner in the desired form factor, complete with the computer software needed to perform signal acquisition and all functions for display, archiving and retrieving the acquired images.

This scanner should be demonstrated to acquire human images, under an IRB-approved research protocol. One fully functional prototype will constitute the third deliverable, accompanied by validation test reports and other relevant reports and designs. Provide an FDA regulatory plan to illustrate the pathway to clearance. The contractor should refine and implement their regulatory strategy for obtaining FDA approval of their technology for use as an US device based on their initial FDA feedback.

This phase should culminate in submission to the FDA of the developed technology for approval. In conjunction with FDA submission, the contractor should develop scaled up manufacturing of the technology that follows FDA quality regulations. In addition, the work may result in technology transition to an Acquisition Program managed by the Service Product Developers. The contractor can also propose use to the Services.

Utility would be enhanced if the device was easily able to transmit images from phone internet application s , enabling teleradiology and potentially integrate with artificial intelligence. The ability to provide a non-contact ultrasound device to the battlefield space will enable better visualization of injuries without the need to remove clothing and protective gear before it's necessary to treat.

OBJECTIVE: Design and build a Terahertz THz medical imager in the form of a small, flexible, layered rectangular blanket, with internal functional components, that can be wrapped around the torso of a wounded patient and provide images of internal anatomy.

THz radiation has frequencies in the range 0. THz waves can penetrate clothing, among other solid objects, and are now used in some airports to scan passengers and detect dangerous items. THz radiation is an advantageous electromagnetic frequency band for medical imaging due to its low probability of causing tissue damage, since low energy THz photons are non- ionizing and are strongly absorbed by water.

THz radiation can produce extremely high resolution images, and is able to image subtle tissue differences due to its high sensitivity to water content. Previously, technical issues prevented construction of practical THz medical imagers.

Recently, though, several critical technology advances in THz transmitters and detectors have appeared in the literature. These advances include flexible terahertz detectors using nanotube [1] and graphene [2] and nanowire technologies [3], and a flexible terahertz transmitter [4] using nanoscale technology.

In combination, these technologies make it possible to design a flexible, lightweight, portable THz medical imager. One can envision that such an imager can be easily carried and used in many situations to provide imaging capability [5,6]. The THz imager may provide medical images that can reveal acute traumatic injury, e. THz imaging methodology challenges still exist. Scientists have devised a number of methods to extract biomedical information using different forms of THz imaging, as reviewed in [6].

THz phase contrast imaging seems the most successful [6] for biomedical imaging since it offers information about interior density, while absorption techniques are limited to surface imaging due to the strong water absorption of THz waves. Imaginative design is encouraged, to minimize weight, increase signal-to-noise ratio SNR , and guarantee robustness in demanding conditions.

The imager is to be sized 60 cm long x cm wide to wrap and provide medical images from the torso, showing internal organs. Smaller prototypes can be used in testing. The THz imager has value in primary care, trauma care, and image-guided interventions. This project involves much innovation and state-of- the-art science, but the THz imager product has the potential to open up a new field and business in medical imaging.

Military applications of the imager for trauma care also exist, presenting special challenges particularly in the rapid assessment of internal injuries and hemorrhage, and medical monitoring. To prove feasibility, a physical, electronics, and circuit design of the flexible THz imager product should be completed as the first deliverable. The electronic and circuit designs should include the latest in scientific components for THz transmitter and detector.

It must be shown in the feasibility study that the THz imager can be fabricated. Battery power should accommodate two hours of use prior to recharging and comply with Army field battery usage.

An added benefit would come from the computer simulation of the first deliverable showing expected operation. Subcontractor s should be identified and give written proof of abilities and cooperation if component construction is out-sourced. The second deliverable is the physical design of the imager.

The physical design of the THz imager must accommodate the scientific and technical elements identified in the first deliverable. Component costs may limit the size of the demonstration product. It must have a disposable sterilized cover or be able to be easily cleaned and sterilized.

A good example is a flexible MRI receiver coil. Imaginative design and fabrication ideas are encouraged. The imager must be able to operate under normal environmental conditions but it would be an added plus if the product could be designed to operate under extreme temperature conditions experienced by the military see [7].

The third deliverable is the technical design of the data acquisition � that is, the data acquisition methodology, image reconstruction, filtering options, display, image transmission and archiving using DICOM format. The imaging methodology must be robust and efficient, e. THz phase contract imaging that can acquire and display internal anatomy, i. The imaging methodology must be designed for power deposition within FDA guidelines.

Subsequent signal processing steps must be identified or designed. Image reconstruction, filtering, and display should occur on an Android handheld computer or IVAS goggles. The handheld computer must be capable of performing the image reconstruction computations at a rate of approximately 1 image per second or faster if possible, from the acquired data.

This computer should also be able to transmit the images by wire or wirelessly to an external device. PHASE II: The overall objective of Phase II is to produce a fully operational prototype of the flexible THz imager, scaled in size, that can acquire in vivo human images in tests, archive and display the images on external devices, retrieve the images from the archive and redisplay them..

Experimental proof of power deposition will be required to show compliance with FDA guidelines. The first goal of Phase II is to produce scaled prototype imager hardware based on the design of Phase I. This task will produce the first deliverable, a prototype of the THz imager that acquires signals from an inanimate phantom that can be observed on an oscilloscope.

Testing of improvements and changes is then encouraged in order to take advantage of the state-of-the-art in electronics, computers and other components of the prototype.





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