SBIR-STTR Award

We will design, manufacture, and test a prototype to assure 35 degree upper torso elevation for adults with severe brain injury or dementia. These adults are unable to maintain this medically-essential bed position during enteral feedings. Assurance of this upright position reduces risk of formula aspiration and subsequent pneumonia secondary to gastroesophageal reflux. Unfortunately, no existing product or nursing measure currently employed meets the unique positional needs of this growing population of end-users. In a recent four month experiment, significantly less aspiration and pneumonia occurred when a wedge-type product designed by researchers was used to maintain upper torso elevation. A Phase I award will support technological resources to perfect and test a more serviceable, comfortable, safe, and user friendly product. The design will incorporate a pneumatic component and lateral supports to stabilize position and facilitate caregiver use. Feasibility will be determined by using serial photography, bedside observations, and rating scales completed by the principal investigator, nursing staff, and families. Design modifications large scale testing and marketing for institutional and home settings will occur in Phase I. The company plans to patent and mass produce several standard and customized products by the end of Phase lll.Awardee's statement of the potential commercial applications of the research:End-users include the large and growing number of adults who are survivors of severe brain injury, those with significant dementia, and those with advanced pulmonary emphysema. All of these adults would benefit from upper torso elevation assistance in hospitals, long term care facilities, and during care at home.National Institute on Aging (NIA)

Design-Able, Inc. plans to conduct a multi-site experiment to determine effectiveness, comfort, and safety of two positional prototypes that maintain a 30 degree, upper torso elevation. One prototype features a pneumatic design with "automatic centering" to counter positional loss. The other prototype, constructed with a soft center and firm sides, stabilizes position for adults with severe dystonia. Prototype evaluation incorporates 12 hours of individual bedside observations and serial still photography with 90 subjects. The company expects to achieve a 50 percent improvement over a standard treatment of raising the head of the bed. The end users for these positioners include most total care adults who cannot sustain this medically essential, bed position independently. They share several characteristics: immobility; severe cognitive and/or physical impairments; are usually fed enterally by gastrostomy tube; have a high incidence of pulmonary aspiration and pneumonia. The upright position reduces risk of aspiration and facilitates ventilation. Unfortunately, no product or nursing measure currently employed meets the unique positional needs of this growing population. A Phase 2 Award will support minor prototype changes, fabrication, and testing in five long term care institutions. The company will mass produce and market these products in Phase 3.Proposed commercial application:Prevention as a cost-saving measure in health care implies that caregivers will anticipate potential problems and intervene appropriately. Yet, aspiration pneumonitis, a preventable health problem, ranks as the second most common nosocomial infection costing millions of dollars annually. Caregivers attempt to position high risk adult upright and reposition them every two hours. But with limited staff, vigilant caregivers cannot ensure the maintenance of this upright position within the two hourly period. To counter this spiraling and expensive dilemma, most health care institutions, staff, and patients could benefit from use of an assistive device to ensure position which is less costly than treatment for pneumonia. Caregivers working alone within an institution or home setting could also benefit as a single caregiver can apply the pneumatic product without seeking extra help.Thesaurus termsbiomedical equipment development, hospital equipment /supply, posture, restraint, restricted physical activity dystonia, immobilization of body part clinical research, human subjectNational Institute on Aging (NIA)