This proposal seeks to develop, test, gain regulatory approval and distribute for continuing evaluation, a lightweight, broadly useful children's wheelchair that is suited particularly for high-tone children. The chair is comprised of a synthetic resin-based, wheelchair chassis mated to newly developed, compliant seating that corrects, aligns, and supports the child's individual structural deviations. The proposal produces preproduction units based on the model plastic chassis and dynamically compliant seating prototype demonstrated with SBIR Phase I support. This development is part of a larger effort to extend the freedom of wheelchair design and materials use that Turbo Wheelchair exhibited with the all plastic adult wheelchair, Merlexi Craft}. This proposed children's wheelchair would support the NICHD mission to strive for healthy functioning of infants, children, youth and families and to support research to help persons with physical disabilities restore, replace, enhance, and prevent decline in function. Experts specify unmet needs in wheelchairs for individuals with high tone. They require durability, light weight, adjustability, dynamic seating and modular components. These needs are especially critical for the wheelchair bound among the 100,000 children with cerebral palsy. Turbo Wheelchair will refine the plastic chassis components fabricated in Phase I to minimize the weight and redesign the caster assembly for greater durability. The air-supported seat concept introduced in the Phase I model will be refined to idealize correction and alignment forces using expertise at CATEA (Ga. Tech) and Children's Healthcare of Atlanta. Prototype chassis will be assembled from molded components after fabrication of molds (Caro Polymers, Bessemer City, NC). Seating components will be developed with Folbot, Inc., North Charleston, SC. Mated components will undergo human studies testing and physical test and human studies data will be used for a redesign phase. Redesigned prototypes (24) will be fabricated for a second human studies evaluation, durability testing and functional review by a panel of scientific/medical experts. Pending successful review, the Company will file for FDA approval for sale and distribute a number of assembled chairs to children's medical center for internal use and comment prior to Phase III commercialization.
. The need for a range of assistive devices that respond to the needs of a broad range of disabled individuals is a desirable public health goal. Further, another demonstration of the design capabilities and the durability and versatility of plastic vs. metal wheeelchair devices can lead to consideration of new designs in synthetic materials throughout the medical device industry thus broadly benefiting medical care. ? ?
