SBIR-STTR Award

A June 1991 CDC estimate shows that the American AIDS crisis has led to 115,984 dead, 182,834 suffering with AIDS, and 1 million who are HIV positive. Intravenous (IV) drug users have been identified as major vectors for the spread of AIDS in the general population because of their sharing and re-use of hypodermic needles. With no vaccine in sight, and re-education time-consuming and sometimes ineffective, a technological solution to discourage needle-sharing is imperative. One such solution is the development of a competitively priced, single-use automatically and permanently retracting syringe. The purpose is to build working prototypes of an innovative solution to the retraction function. The unique location of the retraction spring produces a retraction force three hundred percent greater than other such products, while tremendously enhancing reliability and lowering cost. Experts in the field of material/science and medical device manufacturing, who have evaluated this concept, have unanimously concluded that the approach is feasible. They have also concluded that device designs utilizing lessor amounts of spring energy are unlikely to prove reliable. This project fully addresses the problems of design, materials selection for reliability, cost and manufacturability.Awardee's statement of the potential commercial applications of the research:Currently, in excess of six million syringes are consumed every day in the United States. Shortages in Africa and similarly underdeveloped areas have resulted in the continued practice of syringe re-use, even by health care workers. Pain killers such asNational Institute on Drug Abuse (NIDA)

An estimate in December 1992 shows the magnitude of the American AIDS crisis to be 171,890 dead, 81,558 suffering from AIDS, and an estimated I million HIV positive (CDC). Intravenous (IV) drug users have been identified as major vectors for the spread of AIDS in the general population because of sharing and re-use of hypodermic needles. With no vaccine in sight and re-education lengthy and sometimes ineffective, a technological solution to discourage needle-sharing is imperative. One such solution_a competitively priced, single-use automatically and permanently retracting syringe - was developed during Phase I of our project. Phase I research resulted in manufacture of several working prototypes suitable for mass production and clearly demonstrating that the innovative solution to needle-sharing is the retraction function that makes sharing impossible. There are five main objectives of Phase II: I) refinement of the Checkmate Engineering (CE) 3cc non-reusable, retractable syringe to a production model, 2) production of 50,000 of the CE 3cc syringe for clinical testing; 3) development of a 1cc non-reusable retractable syringe utilizing a similar retraction mechanism; 4) clinical testing for acceptance of the CE 3cc syringe at Parkland Memorial Hospital, TCOM, Dallas County Health Department, Denton County Health Department, Dallas Home Therapeutics I, Inc., Texas Health Resources and ten private physicians selected from throughout the Dallas-Fort Worth metroplex; and 5) formulation of a Phase III business plan.Awardee's statement of the potential commercial applications of the research: The P. I. has been issued two syringe patents; a third in the final stages of approval pertains to alternative methods of utilizing the unique location of the retraction spring. Aside from the obvious commercial potential of a new device that could replace the six million syringes consumed daily in the United States, there are numerous other needle products that could benefit from low-cost, automated retraction technology.National Institute on Drug Abuse (NIDA)