SBIR-STTR Award

Prosthetics Our goal is to create a "transtibial prosthesis in a kit" that can be inexpensively manufactured using modern technology and advanced polymer materials. This system will be immediately fit on the residual limb and aligned for optimal gait without specialized tools or labs. Such a system alleviates the many steps involved with conventional prosthesis construction which is costly and labor intensive. The primary market for the proposed prosthetic system is impoverished third world countries. The market for such a system is large and consists of foreign healthcare organizations and ministries, the World Health Organization, and the U.S. Military which frequently supports humanitarian missions. A secondary market is in the early rehabilitation of amputees when the limb is changing size and shape in more economically advanced nations. Transtibial amputations due to trauma and dysvascular diseases are the most commonly performed levels of amputation in this country and worldwide and are the focus of this project. Our four year collaboration with Advanced Design Concepts (ADC) engineering firm has been quite successful to date in developing our preliminary prototype design. Continued collaboration with the principal business interest in this study, "iFIT Prosthetics, LLC" will enable us to develop the second generation prosthetic system. In this project, our aims are;i) to design and build the next generation prototype transtibial prosthetic system building on our experience and using a focus group of amputees for consumer input, ii) to conduct a pilot feasibility study on 10 volunteer subjects using biomechanics testing and quantitative surveys, and iii) to derive a final prototype and retest it using finite element analyses in preparation for ISO testing and commercialization. The results of this STTR project could change the way in which lower limb prostheses are provided in underdeveloped nations. The field of lower limb prosthetics can benefit greatly from advanced materials and fabrication techniques. Such innovations hold considerable promise to advance the science and practice of rehabilitation for these individuals.

Public Health Relevance:
Prosthetics Our company's goal is to create a "transtibial prosthesis in a kit" that can be inexpensively manufactured using modern technology and advanced polymer materials. This system will be immediately fit on the residual limb and aligned for optimal gait without specialized tools or facilities. Such a system will benefit amputees in impoverished countries as well as amputees in economically advanced nations. This innovative, highly-functional alternative to the current state of prosthetic fabrication holds great potential to advance the quality of life for amputees worldwide.

Thesaurus Terms:
0-11 Years Old;1,3-Butadiene, 2-Chloro-, Homopolymer;21+ Years Old;Address;Adult;Amputation;Amputees;Armed Forces Personnel;Artificial Limbs;Biomechanics;Businesses;Care, Health;Certification;Child;Child Youth;Children (0-21);Chloroprene Polymer;Collaborations;Country;Developing Countries;Developing Nations;Development;Devices;Disease;Disorder;Duprene;Engineering;Engineerings;Ensure;Environment;Evaluation;Extremities;Extremities, Artificial;Feasibility Studies;Finite Element Analyses;Finite Element Analysis;Focus Groups;Foundations;Fungi, Filamentous;Gait;Generations;Goals;Guidelines;Healthcare;Hour;Human, Adult;Human, Child;Hydrogen Oxide;Individual;Injection Of Therapeutic Agent;Injections;Laboratories;Less-Developed Countries;Less-Developed Nations;Limb Prosthesis;Limb Structure;Limbs;Lower Extremity;Lower Limb;Marketing;Mechanics;Membrum Inferius;Methods;Methods And Techniques;Methods, Other;Military;Military Personnel;Mission;Modeling;Molds;Neoprene;Non-Trunk;Pain;Painful;Pattern;Phase;Physical Health Services / Rehabilitation;Polychloroprene;Polychloroprenes;Polymers;Preparation;Principal Investigator;Prosthesis;Prosthetic Device;Prosthetics;Qol;Quality Of Life;Recruitment Activity;Rehabilitation;Rehabilitation Therapy;Rehabilitation, Medical;Residual;Residual State;Sttr;Science;Shapes;Skin;Small Business Technology Transfer Research;Staging;Standardization;Survey Instrument;Surveys;Suspension Substance;Suspensions;System;System, Loinc Axis 4;Techniques;Technology;Testing;Third-World Countries;Third-World Nations;Time;Trauma;Under-Developed Countries;Under-Developed Nations;United States;Who;Water;World Health Organization;Adult Human (21+);Base;Children;Commercialization;Design;Designing;Disease /Disorder;Disease/Disorder;Experience;Health Care;Improved;Innovate;Innovation;Innovative;Innovative Technologies;Interest;Light (Weight);Meetings;Model;Next Generation;Prototype;Recruit;Rehabilitative;Success;Suspension;Tool;Volunteer;Youngster

Our companys'goal is to create and commercialize a modular, immediate fit, transtibial prosthesis system at a fraction of the cost of conventionally manufactured devices. Our product will be mass produced using the latest injection molding techniques with advanced materials that duplicate the strength of metal at a fraction of the cost. This system will be immediately fit on the residual limb and aligned for optimal gait without specialized tools or facilities. The advanced prototype incorporates a new socket that uses a buckle system ? similar to a ski boot ? with a rear entry panel that allows for fine adjustments to optimize fit and comfort. Our new design has been well received by subjects to date and biomechanical testing revealed gait patterns similar to those with their conventional devices. The goals and aims for Phase I were fully met and we demonstrated the feasibility of immediate fit prosthetics. Phase II funding is now necessary to fully test, develop, and commercialize our novel device ?a self-contained transtibial prosthesis system that is immediately fit and provides a high level of comfort and functionality. Our collaboration with Advanced Design Concepts (ADC) and their engineering team has been highly successful in developing our current product. The principal business interest in this study ""iFIT Prosthetics, LLC"" is well poised to carry out te aims of this Phase II project under the direction of the primary investigator (Dr. Dillingham). Thi proposed two year project will bring our prototype product to the point of, marketing, sales, and commercialization. The specific aims of this Phase II project are threefold. First we will test 30 unilateral transtibial amputees at more intense levels of ambulation, assessing comfort, ease of use and stability with our device. Second, ADC Engineering will fabricate metal templates for injection molding our prototypes and then produce 50 transtibial prostheses. Third, ADC Engineering will conduct International standards testing on our devices to insure they exceed international standards for strength and durability. Concurrent with this testing and manufacture, iFIT Prosthetics will develop web-based sales capabilities and educational materials for prosthetists that will use our product as part of a commercialization plan. The market for this device is quite large internationally and in the United States. Our future customers are many and include;i) amputees from impoverished countries for whom conventional manufacture and prosthesis fitting are cost prohibitive, ii) amputees who experience volume changes in their residual limb shortly after amputation or because of heart and renal diseases, and iii) pediatric amputees who are growing and need an adjustable, comfortable prosthesis. Currently, there are no commercially available devices such as ours on the market. Our product will be introduced at a considerable cost advantage relative to standard prostheses, yet is equally as comfortable and functional. The concept iFIT Prosthetics is advancing?immediate fit devices? could well lead to changes within the prosthetics industry.

Public Health Relevance:
iFIT Prosthetics Our company's goal is to create and commercialize a modular, immediate fit, transtibial prosthesis system at a fraction of the cost of conventionally manufactured devices. Our product will be mass produced using the latest injection molding techniques with advanced materials that duplicate the strength of metal at a fraction of the cost. This system will be immediately fit on the residual limb and aligned for optimal gait without specialized tools or facilities. Our prototype for this Phase II project utilies a rear-entry buckle system that easily adjusts to different residual limb shapes and sizes. Such a system will benefit amputees in impoverished countries where conventional devices are not readily available due to high costs, as well as amputees in economically advanced nations who require socket adjustments to accommodate changes in shape and volume. This innovative, highly-functional alternative to the current state of prosthetic fabrication holds great potential o advance the quality of life for amputees worldwide and change the field of prosthetic rehabilitation.