NASA SBIR 2005 Solicitation


PROPOSAL NUMBER:05 X11.02-7626
SUBTOPIC TITLE:Human Health Countermeasures
PROPOSAL TITLE:Transcutaneous Noninvasive Device for the Responsive Delivery of Melatonin in Microgravity.

SMALL BUSINESS CONCERN (Firm Name, Mail Address, City/State/Zip, Phone)
Technova Corporation
1232 Mizzen Drive
Okemos ,MI 48864 - 3480
(517) 485 - 9583

PRINCIPAL INVESTIGATOR/PROJECT MANAGER (Name, E-mail, Mail Address, City/State/Zip, Phone)
Serban F. Peteu
1232 Mizzen Drive
Okemos, MI  48864 -3480
(517) 485 - 1402

Our goal is develop a smart, transcutaneous device for individualized circadian (sleep) therapy by responsive release of melatonin, in microgravity. Additionally, this concept ?shown in figure 1?is modular and multifunctional by design. So, with minimal changes, we envision being able to use same device for the controlled release of other medicines and nutrients, in space as well as on Earth. For space-travel, a variety of countermeasures must be developed to oppose the harmful effects of longterm flights and exposures to other gravitational fields. Furthermore, each astronaut responds to a certain medicine or combination of medicines in a unique manner. Circadian disruption, or acute (chronic) degradation of sleep quality or quantity, is a known risk during space-flight. Techova will develop a unique device for the responsive delivery of melatonin, integrating (i) inherently conductive polymer-based valves, (ii) nano- and micro-structured sensors and (iii) non-invasive virtually pain-free micro-needle arrays. Our team builds upon previous research critically needed to develop this novel transdermal release device. The ability to monitor the progression of circadian (sleep) disruption and respond to the unique changes in the body chemistry of each individual (patient) offers an unprecedented opportunity to deliver specific, personalized medical care during space flight.

The chronic reduction of sleep duration in space result in fatigue and jeopardize astronaut performance. American, Russian and European studies of sleep in space found that daily sleep is reduced to an average of 6 hours, or more during critical operations. Astronaut sleep in space is also physiologically altered (Anon., 2004).
During Phase 1, we will establish the merit, feasibility and fabrication of a working prototype of a new transcutaneous device for controlled release of melatonin circadian (sleep) therapy. During Phase 2? we will prepare an integrated electrochemical sensor to monitor the level of melatonin in the interstitial fluid (ISF) and thus guide the individualized regimen in a closed loop control with personalized algorithm. At same time, a NASA-associated collaborator will be recruited to test this responsive device on small animals. A simple model, like glucose closed loop (responsive) control for diabetic rats, will be used both in Earth gravity and in simulated microgravity.
Professor Mark Prausnitz (Georgia Tech) and Professor Moshen Shahinpoor (University of New Mexico) will assist to ensure a smooth transition to Phase 2.

Back on Earth, a major technological limitation of all commercially available controlled release systems, including the transdermal wearable patches, is that they are not responsive to an individual's need for drug therapy. Rather, these systems operate with a predetermined regimen, based on population averages. However, every individual has unique needs for therapy and develops a unique reaction to a particular regimen. Thus, drug administration based on averages often results in over- or under-dosing, outside of the optimal therapeutic window. An additional challenge for current drug delivery systems is that of compliance. Over 2/3 of patients are "non-compliant" ? they do not take medication on time and in the correct dose. This lack of compliance leads to an estimated 125,000 deaths annually, in the U.S. alone. It is expected that the responsive therapeutic systems developed with our technology will overcome these issues with its capability to provide reliable, accurate, smart dosing. Integrated Sensing Systems Inc. and Environmetal Robots, Inc. have shown an interest in our technology and are ready to partner with us to refine, optimize and commercialize the prototype. Michigan Development Corporation awarded us $15,000 matching funds for Phase 1.

NASA's technology taxonomy has been developed by the SBIR-STTR program to disseminate awareness of proposed and awarded R/R&D in the agency. It is a listing of over 100 technologies, sorted into broad categories, of interest to NASA.

Biomedical and Life Support
Biomolecular Sensors

Form Printed on 09-19-05 13:12