Lightweight, Dynamically Compliant Manual Wheelchair for Hight Tone Children

适合高音儿童的轻质动态顺应手动轮椅

• 批准号: 7480004
• 负责人: MATTHEW E HERMES
• 金额: $ 41.16万
• 依托单位: TURBO WHEELCHAIR COMPANY, INC.
• 依托单位国家: 美国
• 财政年份: 2006
• 资助国家: 美国
• 起止时间: 2006-05-01 至 2010-04-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7480004
• 关键词: 13 year old; Address; Adult; Affect; Age; Aging; Air; Anthropometry; Athletic; Award; Back; Beauty; Binding; Brain Injuries; Caliber; California; Caring; Cerebral Palsy; Characteristics; Child; Child Support; Cities; Clinical; Code; Color; Computer-Assisted Manufacturing; Condition; Data; Decompression Sickness; Development; Devices; Dimensions; Disabled Persons; Economics; Elements; Engineering; Evaluation; Exhibits; Family; Freedom; Goals; Health; Healthcare; Hospitals; Human; Income; Individual; Industry; Infant; Institutes; Lead; Life; Manual wheelchair; Manuals; Marketing; Mechanics; Medical; Medical Device; Medical center; Metals; Mission; Modeling; Molds; Movement; Musculoskeletal Equilibrium; National Institute of Child Health and Human Development; Neurology; Neurorehabilitation; Numbers; Partner in relationship; Pattern; Persons; Phase; Plant Resins; Plastics; Polymers; Population; Positioning Attribute; Preparation; Production; Public Health; Published Comment; Range; Reflex action; Reporting; Research; Resources; Sales; San Francisco; Science; Self-Help Devices; Site Visit; Small Business Funding Mechanisms; Small Business Innovation Research Grant; Spastic Cerebral Palsy; Specific qualifier value; Support of Research; Surveys; Synthetic Resins; System; Target Populations; Testing; Time; United States; United States Food and Drug Administration; Universities; Update; Visual; Weight; Welding; Wheelchairs; Work; authority; base; commercialization; concept; density; design; disability; ergonomics; functional decline; human study; light weight; prevent; programs; prototype; rehabilitation engineering; statistics; success; symposium; user centered design

DESCRIPTION (provided by applicant): 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. PUBLIC HEALTH RELEVANCE. 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.

描述（由申请人提供）：该提案旨在开发、测试、获得监管部门的批准并分发以进行持续评估，一种轻质、用途广泛的儿童轮椅，特别适合高音儿童。该椅子由合成树脂轮椅底盘组成，与新开发的合规座椅相匹配，可纠正、对齐和支撑儿童的个人结构偏差。该提案基于模型塑料底盘和在 SBIR 第一阶段支持下演示的动态兼容座椅原型生产预生产单元。这一开发是 Turbo Wheelchair 与全塑料成人轮椅 Merlexi Craft} 一起展示的扩大轮椅设计和材料使用自由度的更大努力的一部分。这款拟议的儿童轮椅将支持 NICHD 的使命，即努力实现婴儿、儿童、青少年和家庭的健康功能，并支持帮助身体残疾人恢复、替代、增强和防止功能衰退的研究。专家指出，高语气人士对轮椅的需求尚未得到满足。它们需要耐用性、重量轻、可调节性、动态座椅和模块化组件。这些需求对于坐轮椅的 10 万名脑瘫儿童来说尤其重要。 Turbo 轮椅将改进第一阶段制造的塑料底盘组件，以最大程度地减轻重量，并重新设计脚轮组件以提高耐用性。第一阶段模型中引入的空气支撑座椅概念将利用 CATEA (Ga.Tech) 和亚特兰大儿童医疗中心的专业知识进行改进，以理想化校正和对准力。原型底盘将在模具制造后由模制部件组装而成（Caro Polymers，北卡罗来纳州贝塞默市）。座椅组件将与南卡罗来纳州北查尔斯顿的 Folbot, Inc. 共同开发。配合组件将接受人体研究测试和物理测试，人体研究数据将用于重新设计阶段。重新设计的原型 (24) 将由科学/医学专家小组进行第二次人体研究评估、耐久性测试和功能审查。在审核成功之前，该公司将向 FDA 申请销售批准，并将一些组装好的椅子分发给儿童医疗中心供内部使用，并在第三阶段商业化之前征求意见。公共卫生相关性。需要一系列能够满足广大残疾人需求的辅助设备是一个理想的公共卫生目标。此外，塑料与金属轮椅设备的设计能力、耐用性和多功能性的另一次展示可以促使整个医疗设备行业考虑合成材料的新设计，从而广泛惠及医疗保健。