SBIR-STTR Award

?The Specific Aim of this Phase I project is to prove the feasibility of using SFC Fluidics' patented microfluidic pumping technology to develop the RatPump, a low-cost, disposable, battery-operated, implantable, on-demand, tether-free drug delivery system. The RatPump will allow real-time wirelessly controlled delivery of drugs and therapeutics to animals for addiction and behavior research models. This implantable pumping system will have substantially improved operational capacities at a much lower cost as compared to current tethered and non- tethered drug delivery systems. During the last three months of Phase I, the RatPump will be implanted and tested in rats at the McLean Psychiatric Hospital at Harvard University. The following Phase I Tasks are designed to prove feasibility of this Specific Aim. Task 1: Integration of microfluidic components into an implantable, on-demand drug delivery device. (SFC Fluidics - Months 1-4) Task 2: Demonstration of controlled fluid movement ex vivo from the drug delivery system using specified test protocol. (SFC Fluidics - Months 5-6) Task 3: Demonstration of use of implanted RatPump showing ability to deliver drugs on- demand and remotely. (Harvard/McLean Medical School - Months 7-9) Phase II will focus on modifying the Phase I RatPump prototype based on the results of Phase I testing and iterative advanced development. By the end of Phase II, SFC Fluidics will have a final design RatPump system that will deliver on-demand doses of drugs and therapeutics with an accuracy of +/- 5%. The focus of our subcontractor in Phase II will be to improve his drug addiction models as enabled by the RatPump, and to provide those data in publications, scientific conferences, and collaborations in order to facilitate the use of the RatPump toward the advancement of drug addiction models in other laboratories.

Public Health Relevance Statement:


Public Health Relevance:
A low-cost, disposable, quick response, programmable or response dependent micropumping system, like RatPumpTM, would have widespread use in behavioral pharmacology and veterinary medicine. This drug delivery device concept targets preclinical animal model research as well as veterinary therapy as market applications. With additional funding, this system could be adapted for implantable drug-delivery needs in humans as well.

NIH Spending Category:
Bioengineering; Biotechnology; Brain Disorders; Drug Abuse (NIDA only); Substance Abuse

Project Terms:
addiction; Advanced Development; Anesthesia procedures; Anesthetics; Animal Model; Animals; base; Behavior; behavioral pharmacology; behavioral study; Biocompatible; Blood; Bolus Infusion; Cannulas; Collaborations; Computer software; cost; Data; design; Development; Devices; Dose; drinking; Drug Addiction; Drug Delivery Systems; Effectiveness; Ensure; Evaluation; external jugular vein; Flavoring; Food; Funding; Genus Vanilla; Goals; Government; Human; Implant; Implantable Pump; improved; Infusion procedures; Injection of therapeutic agent; Laboratories; Legal patent; Liquid substance; Marketing; Medical; medical schools; Methohexital; Microfluidics; Modeling; Movement; Muscle Tonus; Persons; Pharmaceutical Preparations; Phase; Postoperative Period; pre-clinical; Procedures; programs; Proteins; Protocols documentation; prototype; Psychiatric Hospitals; public health relevance; Publications; Pump; Rattus; Recovery; Reflex action; Reinforcement Schedule; reinforcer; Research; Research Personnel; response; Secure; Self Administration; Signal Transduction; Silastic; Sodium; Specific qualifier value; Stream; Study models; symposium; System; Technology; Testing; Therapeutic; Time; Training; Universities; vapor; Veterinary Medicine

Development of an Implantable On-Demand Drug Delivery Device for Behavioral Studies in Small Animals Project Summary: The Specific Aims of this Phase II project are to finalize the development of the min- ePumpTM, a low-cost, battery-operated, wirelessly controlled, on-demand or programmable drug delivery system, and to establish its use in improving drug addiction and drug development models. During Year 1, the min-ePump will be optimized for reliable implantation and comfortable wear in animals as small as a rat. During the second half of Phase II, the pump will be tested extensively to validate this enabling technology for use in drug addiction research, in pre-clinical drug development research and for delivery of therapeutics in veterinary medicine. The end of Phase II will see the definition of manufacturing and operating parameters for min- ePump and publication of research results. The following Objectives will allow for completion of the Phase II project: Objective 1 – Miniaturize and optimize min-ePump for ease-of-use and comfort during implantation in a rat model. Objective 2 – Compare efficacy of min-ePump to traditional tethered-pump in self- administration drug addiction research and test social and behavioral effects of an implanted pump in a rat model. Objective 3 – Show efficacy for use of min-ePump in PK/PD research using a drug addiction therapeutic in a rat model. Objective 4 – Show efficacy for use of min-ePump in veterinary medicine using a dog model. Objective 5 – Finalize the design of the min-ePump to best meet the needs of each target market segment and define the manufacturing process. This project will address two high need technology gaps identified by the NIDA. Under the original Phase I solicitation, this project directly addresses a special needs topic for “Development of pre-clinical models for addiction.” Min-ePump also applies to the programmatic priority released by NIDA in January of 2015 for preclinical drug development enabling technologies.

Public Health Relevance Statement:


Project narrative:
SFC Fluidics’ overarching goal for this project is to develop the min-ePumpTM, a low-cost, implantable, wirelessly controlled, on-demand drug delivery system for small animal research models. During Phase II, the min-ePump design will be finalized and tested in vivo in three important applications: self-administration of a powerful synthetic opiate, pharmacokinetic testing of a drug used to treat opioid overdose, and patch pump administration of veterinary medicine. The min-ePump will be the state-of-the-art in tetherless, on-demand drug delivery.

Project Terms:
addiction; Address; Animal Experimentation; Animals; base; Behavioral; behavioral study; Blood; Canis familiaris; Communication; comparative efficacy; cost; design; Development; Devices; Drug Addiction; Drug Delivery Systems; drug development; Drug Kinetics; Drug usage; Evaluation; Funding; Goals; Government; Hand; Hospitals; Implant; implantation; improved; in vivo; Injection of therapeutic agent; Instruction; International; Intravenous Bolus; Investments; Journals; Liquid substance; manufacturing process; Marketing; Medical; Miniaturization; miniaturize; model development; Modeling; Naloxone; Naltrexone; Names; National Institute of Drug Abuse; North Carolina; novel; Opiates; Opioid; Oral; Overdose; Peer Review; Persons; Phase; pre-clinical; preclinical development; Preclinical Drug Development; programs; Protocols documentation; Publications; Publishing; Pump; Rattus; Research; research and development; Rewards; Sales; Self Administration; social; social stress; Sterilization; subcutaneous; symposium; System; Technology; Testing; Therapeutic; Time; tool; Universities; Veterinary Medicine; Wireless Technology