This Small Business Innovation Research (SBIR) Phase I project focuses on technical feasibility of a remotely-controlled implantable drug infusion pump miniaturized to a standard pill form factor. Technical challenges include the development of a low-power inductively-powered pump actuator, ten-fold pump miniaturization to an unprecedented small form factor for minimally invasive implantation, and implementation of remote programmable control of a large number of implanted pumps. The research strategy and competitive edge lies in the innovation of novel microtechnology-based pump components and wireless inductive power and control technologies. Successful demonstration of the remotely-controlled implantable infusion pump system with external hardware/software controller modules will enable new dosing schemes, provide precise temporally controlled dosing for more reproducible results from acute and chronic studies, and enable new approaches to drug therapy that would not otherwise be possible. Remotely-controlled dosing following a programmable drug regimen would dramatically simplify and expedite experimental studies. These novel pumps can also be adapted or scaled up to treat human disease, especially for advanced drug regimens not available with current commercial pumps.
The broader impact/commercial potential of this project will uniquely facilitate drug development by improving outcomes in scientific and drug discovery, thereby reducing costs early in the development process. The system includes several significant first-to-market capabilities including chronic dosing studies in freely-moving, tether-free animals in naturalistic environments and rapid evaluation of many new drugs at once which are enabled by automation. Importantly, the pump system enables studies that are performed in a manner that will facilitate translation of therapies from animal to human. Our technology will first be deployed to meet critical needs of preclinical pharmaceutical, medical and animal research markets followed by animal care providers in the veterinary market. The long term goal is to apply this technology to implantable drug infusion for clinical use, a rapidly growing market estimated to reach $16B by 2013. The suite of software and hardware technologies is applicable to multiple markets and has the potential to impact healthcare in multiple areas.
This project focused on the technical feasibility of a miniaturized remotely-controlled implantable drug infusion pump. Technical challenges included the development of a low-power inductively-powered pump actuator, ten-fold pump miniaturization for minimally invasive implantation, and implementation of wireless programmable control of a large number of implanted pumps. These pumps feature an innovative micropumping mechanism that harnesses the pneumatic power of a highly efficient electrolysis process. This pumping approach is highly reliable, requires few mechanical moving parts, and is capable of providing accurate, on-demand and programmable dosing in a package small enough to be easily implantable in animals as small as mice. INTELLECTUAL MERIT: This project demonstrated the feasibility of the remotely-controlled implantable infusion pump system and enabled new dosing schemes, provide precise temporally controlled dosing for more reproducible results and enabled new approaches to drug therapy that would not otherwise be possible. Remotely-controlled dosing has the potential to dramatically simplify and expedite experimental studies. These novel pumps can also be adapted or scaled up to treat human disease, especially for advanced drug regimens not available with current commercial pumps. BROADER IMPACTS/COMMERCIAL POTENTIAL: The FluidSync system will uniquely facilitate drug development by improving outcomes in scientific and drug discovery. The system includes several significant first-to-market capabilities including chronic dosing studies in freely-moving, tether-free animals in naturalistic environments and rapid evaluation of many new drugs simultaneously which are enabled by automation. Importantly, the FluidSync pump system enables studies that are performed in a manner that will facilitate translation of therapies from animal to human. Fluid Synchrony is woman and minority owned and created additional medical device industry jobs for underrepresented students, engineers and scientists. OUTCOMES The work performed during the Phase I/IB demonstrated the feasibility of (1) miniaturizing and integrating a multi-component Fluid Sync wireless micropump, (2) developing a wireless power base station and control software, and (3) operating the system within the desired range. Fluid Synchrony met or exceeded all proposed acceptance criteria. Demonstration of a micro electrolysis actuator, within a wireless, batteryless pump was accomplished. In addition, control of dosing performance (flow rate) over a range that exceeded the initial target of 1−100 uL/hr by more than 100% (>200 ul/hr) was achieved. This performance was shown to be both reliable and accurate with better than ± 10% full-scale accuracy. The ability to refill the pump at least 10 times was a key target which was exceed by more than 500% with a demonstrated refill lifetime of up to 50 refills. Untethered pump operation was shown to be feasible up to 10 cm vertical separation from the base station with excellent uniformity. End-user derived pump size and weight targets were also achieved. Together, these pump-specific performance metrics satisfy a core set of acceptance criteria derived from primary customer input. The complete FluidSync Drug Delivery system was capable of automated operation for an extended period of time (> 2 weeks with pump refills) without issue, exceeding the stated goal of at least 1 week of automated operation. A customer-ready version of the rodent-based FluidSync micro infusion system was successfully developed and deployed with early adopters to evaluate the performance of thep pump, assess surgical/refill protocols, and initiate pilot studies. Lastly, Fluid Synchrony demonstrated in vivo operation of the FluidSync system in a highly successful validation study. The outcome of this study further confirmed the feasibility of implementing this micropump technology in mice which is the first demonstration of its kind in the field. The success of this validation study further enhanced the extent to which all stated acceptance criteria were met. The high level of technology readiness demonstrated through Fluid Synchrony’s Phase I/IB efforts provides a clear path for commercial development of this novel technology. We believe this work has de-risked many of the core elements of the technology, has clearly demonstrated the feasibility of the project and has significantly advanced the state of the art.
