Warrior Health Care
Using small business initiatives to bring about solutions.
Small business has long been recognized as a driving force in innovative technologies and creative solutions in almost every aspect of the American marketplace. The military is no exception and several programs are strongly funded and supported that look beyond the mega companies push solutions up from smaller ones.
MMT looks at a variety of small business solicitations that seek capability improvements in areas of direct benefit to the warrior.
AUTONOMOUS AIRWAY MANAGEMENT
Of the severe casualties with survivable injuries who eventually die of their wounds, the three major causes of death are: exsanguinating hemorrhage, tension pneumothorax, and airway compromise. The U.S. Army has had tremendous success in reducing combat casualty deaths through a combination of improved personal protective equipment (PPE) and improved medic training through the 68W program (formerly 91W), while the Air Force has improved survival through the advances in equipment and training for en-route care. All of these programs have increased the training, equipment and support of airway maintenance and ventilation. Obtaining a secure airway in the polytrauma patient is an essential element of combat casualty care in the “platinum ten minutes.”
Rapid advances in robotics and particularly small-footprint precision robotics have seen a logarithmic growth in the manufacturing world. Modern robots can perform multiple complex tasks with great speed, precision and safety. A robotic system designed to intubate a patient in either an autonomous, defined as supervised operation of the robotic task when unit is placed in the start position within 50 cm of the intended patient, or operator-controlled semi-autonomous mode will eventually solve a number of current problems in airway management in the tactical pre-hospital setting including: reduced medical MANPRINT in remote/ hostile regions; vomiting in non-fasted polytrauma victims, which makes laryngeal mask airways (LMAs) and surgical airways problematic; and the introduction of hemorrhage control devices that may require anesthetizing the casualty and thus necessitating airway and ventilatory support.
The objective of this project is to design and develop a single-man portable robotic endotracheal intubation system, which can operate in autonomous or semi-autonomous modes, to augment the treatment of casualties in theater.
HANDHELD DEVICE FOR MULTIPLEX ANALYSIS OF PROTEINS IN BLOOD
Soldiers and other warfighters can be exposed to a large number of toxic industrial chemicals and materials from occupational sources, from environmental pollution or as result of military activity; hence an important aspect of force health protection is assessing the extent and effects of toxic and hazardous chemical exposure during deployments. Doing so effectively will require field-portable point-of-care biomarker detection devices that are a small logistical burden, yet are versatile enough to assess exposures to a broad range of potential chemical hazards.
Ideally, the point-of-care analyzer should be a unified device capable of collecting blood samples from personnel in a noninvasive or minimally invasive manner, performing any necessary sample processing and providing results for specific biomarkers within 10 minutes or less. The protein biomarkers will be assayed in a multiplex, multichannel or novel format performing at least several tens of simultaneous or near-simultaneous quantitative assays for proteins of interest in a compact platform. The design of the detection system should support flexible configuration during manufacturing to permit the production of specialized detection platforms for particular applications. In practice, the “biomarker” of toxic insult or of a complex disease state may be a protein expression “signature” or constellation of responses rather than an alteration in the abundance of a single protein.
Therefore, the device must have the capability to algorithmically process data from changes in the signals from a number of different proteins to generate a useful readout of type and level of exposure. The ability to detect and analyze multiple toxicant signatures is desirable. All necessary sample processing should be performed by the device, and integration of sample collection functionality with the device is desirable. The device should operate reliably at the ambient temperatures normally encountered in field operations. The target size for the device is approximately that of personal digital assistant (PDA).
The objective is to develop a point-of-care device to rapidly quantitate tens or more of protein biomarkers simultaneously in blood to assess and evaluate signatures of toxic industrial chemical exposure.
HANDHELD DEVICE FOR MEASURING DRINKING WATER TOXICITY
As part of a research program to identify environmental hazards to soldiers resulting from exposure to toxic industrial chemicals (TICs), the U.S. Army Center for Environmental Health Research (USACEHR) is seeking new methods for providing rapid toxicity evaluation of water samples. Rapid toxicity test kits for water can be helpful for evaluating drinking water quality, but currently-available tests have limitations that substantially reduce the usefulness of the tests for field water testing. Problem areas may include limited capability for rapid response to a wide range of TICs, a need for refrigeration to extend the shelf lives of reagents or test systems, and time-consuming, multi-step sample preparation and test procedures. The project seeks an innovative and creative research and development efforts to provide an efficient, rapid screening tool for TIC-related toxicity in water samples while providing substantial improvements in the limitations of currently available toxicity tests.
The purpose of this project will be to develop a hand-held device using a novel cellbased approach that responds rapidly and with appropriate sensitivity to a wide range of toxic chemicals in water while requiring minimal environmental controls for storage and use.
HANDHELD COAGULATION FUNCTION PROFILER
Hemorrhage remains the major cause of death in potentially salvagable casualties. Recent evidence has shown that up to 1/3 or more of trauma patients present with a blood coagulation defect, particularly in patients who require a massive transfusion. Technology such as thromobelastometry is available to obtain an overall assessment of hemostatic function and efforts are underway to use this technology to guide resuscitation of injured patients, particularly regarding the use of blood products. Current instruments such as the Haemoscope 5000 or ROTEM are not portable enough to be used as a point-ofcare device nor are they rugged enough to be used in forward combat areas to assess overall coagulation function. The desired instrument would have all the capabilities of these devices in providing hemostasis profiles, but operate as a miniaturized, point-of-care device.
This profiler will be a portable, point-ofcare device that can provide a comprehensive analysis of coagulation function including the time to initial clot onset, rate of clot formation, clot strength and fibrinolysis of the clot.
BIODEGRADABLE HEMOSTATIC AGENTS
A recent evaluation of autopsy data from combat casualties revealed that 82 percent died from hemorrhages that were potentially survivable. Of these only 31 percent had injuries that could be treated by means currently available to the field medic. Thus, there is a great need for hemostatic products that are effective against non-compressible wounds. Ideally, this product would be able to stop severe arterial or venous bleeding, be safe and reliable, flexible and easy to use, lightweight, durable and stable at a range of environmental temperatures. For internal application, a biodegradable product would be more desirable than one that required surgery for removal.
This project will develop a hemostatic agent or dressing effective against internal injuries. A biodegradable product would be preferred over one that would need to be surgically removed.
PREDICTIVE IN VITRO ASSAY FOR IN VIVO EFFICACY OF HEMOSTATIC PRODUCTS
Hemorrhage remains a major cause of death on the battlefield. Evidence suggests that about one-third of these deaths occur later than 10 minutes after injury, suggesting that hemostatic dressings, devices and drugs may be useful in reducing deaths from hemorrhage. Current in vitro assays assessing the hemostatic potential of dressings and agents often use blood clotting in test tubes or drops of blood on a particular surface.
Efficacy under such conditions may not translate into demonstrating that a hemostatic product works in stopping bleeding in animal models of vascular injury. An in vitro assay that could predict the in vivo efficacy of a hemostatic product would be highly desirable. The approach taken by the company or their selection of an approved hemostatic product would not be restricted. The assay could be coagulation or adhesiveness based, for example, but this is not a requirement.
This project seeks to develop an in vitro assay that is predictive as to the potential efficacy of hemostatic dressings and agents applied in vivo to stop significant hemorrhages from arterial or venous sites of bleeding.
A POINT-OF-CARE ASSAY FOR THE DETECTION OF COXIELLA BURNETII (Q FEVER) INFECTION IN SOLDIERS DEPLOYED TO IRAQ
Q-fever is a world wide zoonotic disease caused by infection with Coxiella burnetii. This agent is highly infectious for humans by aerosol, where a single organism can cause the disease. Due to Q fever’s worldwide distribution, US military and civilian personnel deployed overseas are at high risk of being infected. Recent studies (1-3) showed that Q fever poses a greater threat to US forces deployed in Iraq than previously predicted. An investigation of febrile illness outbreak among marines at Hit, Iraq, highlights the fact that Q fever is capable of causing localized outbreaks in exposed military personnel with attack rates up to 50percent and perhaps higher (4). Symptoms of Q-fever are easily confused with a variety of other pathogens (e.g., dengue, malaria, leptospirosis, etc.) that require different treatment regimens. The chronic disease form is infrequent, but the consequent endocarditis is often fatal with a reported 65 percent mortality rate. Therefore, early treatment with an appropriate antibiotic is critical. A rapid point-of-care diagnostic assay is urgently needed in order to initiate appropriate treatment and to minimize the impact of the disease on our operational capabilities.
Current diagnosis of Q fever relies mainly on serological methods (5). Although there are commercially available IFA and ELISA tests for Q fever, the serological testing results vary considerably among different laboratories even using the same kit due to the residual egg yolk or tissue culture proteins in the whole cell antigen preparation (1, 6). We envision a FDAcleared, hand-held diagnostic assay capable of determining whether a given blood/serum sample is infected with C. burnetii. Assays capable of detecting C. burnetii specific antigen and/or specific IgM antibody are desired. The principal requirements of a field-capable Q-fever assay are that it should be 1) rapid (less than 30 minutes), 2) easy to use (one or two steps), 3) no need for sample processing, 4) stable (no temperature sensitive reagents will be used), 5) portable, and 6) inexpensive. The performance of the assay should be at least 85 percent as sensitive and specific as current (non-deployable, non-FDA cleared) assays. The test kit should contain all supplies necessary to run the assay. Both positive and negative controls must be included in the test kit.
The objective of this project will be to adapt state-of-the art technology to develop a field-capable assay for diagnosing Q-fever in soldiers deployed to Iraq or other operational areas.
FACILITATING EMERGENCY MEDICAL PROCEDURE RECALL USING A PICTORIAL MNEMONIC SYSTEM
The Office of the Secretary of Defense believes that force health protection needs can be met by developing new approaches. One of the three broad capability areas of particular interest is the delivery of health education and training. Developing and maintaining emergency medical skills among military personnel is an important aspect of combat medic and warrior skills.
Each soldier, according to the Soldier’s Manual of Common Tasks, Warrior Skills, Level 1 (2007), must learn and retain 17 first aid tasks which are described in 99 pages of text. The tasks, many of which require performance in a correct sequence, range from evaluating a casualty to clearing an airway to attending to a severed extremity or open head wound. Learning and recalling specific medical emergency procedures can be a daunting task for medics and soldiers alike. Recall and execution of many of these tasks could mean life or death in an operational environment.
Previous research has demonstrated that providing students with memorization techniques (mnemonic strategies) has resulted in improvements in their ability to recall learned information. Mnemonic strategies are systematic procedures for enhancing memory and are used to facilitate the acquisition of factual information because they assist in the memory encoding process, either by providing familiar connections or by creating new connections between to-be-remembered information and the learner’s prior knowledge.
Memory experts learn to create mental pictures that endure in the mental space. The proposed medical pictorial mnemonic system would depict each emergency medical situation and its procedural steps in a single pictorial form. The pictures that comprise the proposed system would be characterized as intuitive as they will be formed with symbols that will be easily and immediately recognizable to the soldier. Thus, the symbols would require little cognitive effort in determining their meanings. A study by Estrada et al. (2007) using a pictorial mnemonic system for recalling aviation emergency procedures found that the system facilitated the recall of uncommon, unfamiliar terms and phrases in a naïve population to a level comparable to that of highlyexperienced pilots in just one week.
The findings highlighted the potential for such a mnemonic strategy to aid in the encoding of information into long-term memory. The promise in incorporating such a pictorial mnemonic system into the development of soldier skills would be in reducing the expense and time it takes to teach, learn and maintain the procedures, thus enhancing medical safety and preserving vital resources. If nothing else, a pictorial system would serve as an abbreviated checklist, representative of the 99 pages of text.
This project will design an intuitive pictorial mnemonic strategy to facilitate the learning and recall of emergency first aid procedures.
DEVELOPMENT OF A POINT-OF-CARE ASSAY FOR THE DETECTION OF RIFT VALLEY FEVER (RVF) VIRUS
The requirement here is to quickly and accurately determine whether a sick servicemember is infected with RVF virus. RVF has been documented as the No. 4 infectious disease threat to deployed servicemembers using a quantitative algorithm for the prioritization of naturally-occurring disease threats to the U.S. military (ID-IDEAL)—the rapid identification of the pathogen-causing illness is required in order to initiate appropriate treatment and to minimize the impact of the disease on our operational capabilities. In order to minimize medical evacuation and lost-duty time, identification of the pathogen should occur as farforward as possible.
Desired capability/concept of the final product: We envision a FDA-cleared, handheld diagnostic assay capable of determining whether a given blood/serum sample is infected with RVF virus—assays capable of detecting RVF virus antigen and/or RVF virusspecific IgM antibody are desired. The assay must be rapid (less than 30 min), one- or two-step format, and stable (storage at 35 degrees C for two years). The assay should 80 percent as specific and 80 percent as sensitive compared to current gold-standard assays and should require a small (<50ul) sample volume. The assay must be servicemember-friendly (i.e., easy to operate), inexpensive, portable, use heat-stable reagents, and have no special storage requirements. A total of 10 to 25 individual assays should be packaged in a kit that contains all supplies necessary to run the assay. Appropriate controls (to include a positive antigen control or a positive antibody control, depending on whether the assay is an antigen- or antibody-detection assay) must be included in the kit. It is anticipated that the assay will be used in a low-complexity, austere environment, therefore the FDA moderate complexity requirement must be waived.
Ultimately, this project will adapt stateof- the-art technology to develop a handheld, field-deployable assay capable of detecting and identifying Rift Valley fever virus in blood or serum samples from deployed military service members.
DEVELOPMENT OF A POINT-OF-CARE ASSAY FOR THE DETECTION OF CRIMEAN-CONGO HAEMORRHAGIC FEVER (CCHF) VIRUS
The requirement here is to quickly and accurately determine whether a sick service member is infected with CCHF virus. CCHF virus has been documented as the No. 10 infectious disease threat to deployed service members using a quantitative algorithm for the prioritization of naturally-occurring disease threats to the U.S. military (ID-IDEAL)—the rapid identification of the pathogen causing illness is required in order to initiate appropriate treatment and to minimize the impact of the disease on our operational capabilities. In order to minimize medical evacuation and lost-duty time, identification of the pathogen should occur as far-forward as possible.
The final product of this research envisions an FDA-cleared, handheld diagnostic assay capable of determining whether a given blood/serum sample is infected with CCHF virus—assays capable of detecting CCHF virus antigen and/or CCHF virusspecific IgM antibody are desired. The assay must be rapid (less than 30 min), oneor two-step format, and stable (storage at 35 degrees C for two years). The assay should be 80 percent as specific and 80 percent as sensitive compared to current gold-standard assays and should require a small (<50ul) sample volume. The assay must be servicemember-friendly (i.e., easy to operate), inexpensive, portable, use heatstable reagents, and have no special storage requirements. A total of 10 to 25 individual assays should be packaged in a kit that contains all supplies necessary to run the assay. Appropriate controls (to include a positive antigen control) must be included in the kit. It is anticipated that the assay will be used in a low-complexity, austere environment, therefore the FDA moderate complexity requirement must be waived.
This project will adapt state-of-the-art technology to develop a hand-held, fielddeployable assay capable of detecting and identifying CCHF virus in blood or serum samples from deployed military servicemembers.
DEVELOPMENT OF A POINT-OF-CARE ASSAY FOR THE DETECTION OF SAND FLY FEVER VIRUS (SFFV)
The primary requirement of this project is to quickly and accurately determine whether a sick servicemember is infected with SFFV. SFFV has been documented as the No. 13 infectious disease threat to deployed servicemembers using a quantitative algorithm for the prioritization of naturally- occurring disease threats to the U.S. military (ID-IDEAL)—the rapid identification of the pathogen causing illness is required in order to initiate appropriate treatment and to minimize the impact of the disease on our operational capabilities. In order to minimize medical evacuation and lost-duty time, identification of the pathogen should occur as far-forward as possible.
The final product of this research envisions an FDA-cleared, hand-held diagnostic assay capable of determining whether a given blood/serum sample is infected with SFFV— assays capable of detecting SFFV antigen and/ or SFFV-specific IgM antibody are desired. The assay must be rapid (less than 30 min), one- or two-step format, and stable (storage at 35 degrees C for two years). The assay should 80 percent as specific and 80 percent as sensitive compared to current goldstandard assays and should require a small (<50ul) sample volume. The assay must be service member-friendly (i.e., easy to operate), inexpensive, portable, use heat-stable reagents, and have no special storage requirements. A total of 10-25 individual assays should be packaged in a kit that contains all supplies necessary to run the assay. Appropriate controls (to include a positive antigen control) must be included in the kit. It is anticipated that the assay will be used in a low-complexity, austere environment, therefore the FDA moderate complexity requirement must be waived.
The objective of this project is to adapt state-of-the-art technology to develop a hand-held, field-deployable assay capable of detecting and identifying Sand fly fever virus (SFFV) in blood or serum samples from deployed military servicemembers.
COSMETIC COATING TO PROTECT UNCLOTHED SKIN FROM THERMAL (BURN) INJURY
Fire is a constant threat on the battlefield. While clothing provides a primary protection for much of the body, the hands and face are frequently left uncovered as a matter of comfort or for dexterity, access to equipment or situational awareness needs.
Uncovered skin is extremely susceptible to injury in a fire, where the heat flux can range from 10 kW/m2 to over 100 kW/m2. At a heat flux of 40 kW/m2, which is an intermediate value for fire situations that may be encountered on the battlefield, the exposure time required to cause second degree burns on exposed skin is about two seconds, according to the widely accepted Stoll burn injury criterion. At 80 kW/ m2, which is typical of a so-called flash fire, the time to second degree burn is somewhat shorter, but still on the order of a second.
The standard flash fire duration for purposes of evaluation of protective equipment is 3.0 seconds. If the heat flux to the skin were reduced (by means of the proposed protective coating) to 15 kW/ m2, the Stoll model predicts a doubling of the time to second degree burn to four seconds. While this is still a very short time, this doubling of the time to burn could be a significant additional protection in a flash fire situation where the thermal threat is intense, but of relatively short duration. Reducing the heat flux to 10 kW/ m2 increases the predicted time to burn to 10 seconds, a significant amount of additional time to escape or apply protective cover in a fast-moving fire scenario. Thermal energy is transferred to the skin from a fire through three primary mechanisms. These are radiation (the emission of intense infra-red (IR) radiation from the fire), convection (the transfer of heat through the movement of heated gas from the fire source to the skin) and conduction (the direct contact of hot matter such as burning building materials, etc., on the skin).
Different strategies may be employed to counter each of these potential heat transfer mechanisms, and ideally all would be combined in a single product that would simultaneously protect against all routes of thermal energy transfer. Non-limiting examples of material functionality that could potentially be used in developing a cosmetic product to defeat the thermal exposure threats includes IR reflectivity to prevent radiation heating, phase change materials that could absorb heat before it reaches the skin, and intumescent materials that would expand when exposed to heat to form a protective insulation layer on the skin only when needed. While each of these materials technologies is known and has been demonstrated in some form for thermal protection applications (but not as skin protectants), developing a viable cosmetic product for thermal protection of skin that incorporates all the required functionality will be a challenge on several levels. The product must be hypoallergenic, and it must also conform to the physical and enhanced protection performance capabilities listed in accordance to the military specification, MIL-DTL-32000.
This project will develop a topically applied cosmetic formulation that can protect unclothed skin surfaces, such as face and hands, from thermal injury in a fire.
UNIT CASUALTY EXTRACTION TRAINER
Typically live training events do not realistically train units to sustain casualties. Either training units composed entirely of combat medics train heavily in the combat casualty care arena or combined arms units with medics train heavily in combat skills while essentially neglecting combat casualty care. In reality, small unit commanders must be cognizant of the fact that a casualty removes not only that soldier’s firepower, but the firepower of the combat medic and one or two additional soldiers who must assist the combat medic.
The types of injuries seen in OIF and OEF also are not well covered in training. While recent advances in severe trauma simulations hold promise to subject combat medics to the horrific injuries they can expect to see in combat, there has not been a pervasive attempt to subject other soldiers to these types of simulations in order to provide stress inoculation for them. Finally, injuries due to vehicle rollovers and the complications of extracting injured personnel from a damaged vehicle are not typically components of live training events.
This effort seeks to bridge these gaps by producing a live vehicle simulator that can be safely delivered in one of several positions, and configured with various locked, jammed, or removed doors. Special effects, such as smoke, noise, smell, simulated blood and tissue, and secondary fire effects enhance the realism of the simulator. Finally, patient simulators, programmed to replicate not only IED blast but also vehicle rollover injuries, complements the simulator to provide an environment in which small units with embedded combat medics can “train as they fight”—from initial contact to secondary contact to triage to casualty collection and on to casualty evacuation.
The objective of this project will be to produce a realistic vehicle rollover capability that, when accompanied by special effects and patient simulators, serves as an integral part of a training environment that allows units with embedded combat medics to train in a realistic environment from initial contact through casualty evacuation. ♦