Description:
TECHNOLOGY AREA(S): Bio Medical, Electronics
OBJECTIVE: Design and fabricate a wearable and conformable ultrasound transducer system for high resolution imaging of tissues/organs as well as delivering acoustic energy for modulating the function of those organs or tissues.
DESCRIPTION: There is a critical DoD need to develop a system(s) or platform solution to address the capability gap in the medical ultrasound community, with broad applicability to wearable diagnostics and modulation. Current, field portable ultrasound transducer and imaging systems are readily available yet have a number of drawbacks that restrict their use. First, a highly trained technician is required to control the angle and positioning of the ultrasound wand and to decipher the images produced by these systems. Second, the relative size, weight, and power (SWaP) of current systems are restrictive for wide adoption. Third, current systems include only imaging capabilities and do not include the ability to deliver focused acoustic energy with the aim of modulating organ/tissue function (see references 1, 2). Developing ultrasound transducer systems that overcome these challenges is the focus of this topic. A wearable and conformable ultrasound system that could be placed on the body in a static location could eliminate the need for highly trained technician for wand positioning, and enable image processing software systems to read and provide diagnostic measures of the ultrasound images. Likewise, a conformable array of ultrasound transducers could conceivably reduce the SWaP of existing systems to enable broad adoption in home or field scenarios. Furthermore, there is growing interest in therapeutic applications of ultrasound, with new research demonstrating that acoustic energy delivered to tissues and organs can regulate their function. Wearable ultrasound systems may thus offer diagnostic, monitoring, and therapeutic capabilities in a single, lightweight device. The ultrasound transducer need not include a built-in display for imaging. Instead, the device should interface with one or more commercially available handheld displays, such as tablets or smartphones.
PHASE I: Develop preliminary design concept and basic prototype to determine technological feasibility of a low-power, scalable, flexible ultrasound transducer array for pre-clinical animal use. The component must support capabilities for simultaneous imaging and delivery of acoustic energy to targeted regions. The anticipated specifications for the device are left for the proposer companies to decide based on their intended application space. The device should have broad frequency and power capabilities that would be highly flexible and with rapid reconfigurability all within FDA safety limits. The Phase I deliverable is a basic prototype and final report that must include: (1) modeling and simulations of expected imaging and acoustic energy delivery capabilities including power, pressure, frequency, spatial and temporal resolution specifications; (2) testing of modeled capabilities by the prototype in a phantom system; (3) prototype performance metrics, and identification and plan to address deficiencies to be optimized in Phase II; and (4) competitive assessment of the market. Optimizing usability with multiple imaging interfaces will be considered an additional attractive feature. Plans for Phase II should include optimization design goals and key technological milestones to enable pre-clinical testing and evaluation. Phase I should account for time to submit and process all required animal use protocols as appropriate for moving to Phase II. For this topic, DARPA will accept proposals for work and cost up to $225,000 for Phase I. The preferred structure is a $175,000 base period, up to 12 months period of performance, and a $50,000, 3-month option period. Alternative structures may be accepted if sufficient rationale is provided.
PHASE II: Develop and demonstrate a wearable and conformable ultrasound system based on the basic prototype from Phase I. A critical design review will be performed to finalize the design. Particular emphasis will be placed upon prototype size, weight, power, cost, functionality, scalability, flexibility, and the ability to reliably image and deliver focused ultrasound simultaneously. Phase II deliverable will include: (1) a working prototype of the system, including expected life-cycle capabilities; (2) test data on its performance collected in one or more pre-clinical animal models; (3) test data to ensure compliance with relevant regulations from FDA, FCC, IEC, or other organizations for use in animals and/or humans; and (4) projections for manufacturing yield and costs. Phase II should account for time to submit and process all required animal and/or human subjects use protocols as appropriate. Proposers are highly encouraged to clearly segregate research tasks from human and/or animal testing tasks to allow for partial funding while approvals are being obtained. For this topic, DARPA will accept Phase II proposals for work and cost up to $3,000,000 for a period of up to 36 months. This amount and duration will be inclusive of an Option period. Proposers will be expected to propose the appropriate duration and cost needed to accomplish the work. Phase II awards and options are subject to the availability of funds.
PHASE III: Advanced device for at home/field use by civilians/soldiers in clinically relevant applications. Advanced bio-electronic medicine applications for civilians/soldiers to diagnose and/or treat local or systemic inflammation, traumatic brain injury, organ dysfunction, or other clinically relevant applications.
REFERENCES:
1: Tyler, WJ., et al., Remote Excitation of Neuronal Circuits Using Low-Intensity, Low-Frequency Ultrasound. PLoS One. 2008
2: 3(10):e3511.
3: Juan, EJ., et al., Vagus Nerve Modulation Using Focused Pulsed Ultrasound: Potential Applications and Preliminary Observations in a Rat. Int J Imaging Syst Technol. 2014 Mar 1
4: 24(1): 67–71.
KEYWORDS: Ultrasound, Acoustic Energy, Advanced Electronics, Wearable Electronics, Flexible Electronics, Computer Aided Engineering, Design For Manufacture, Design For Test, Fabrication, Integrated Product And Process Design, ASIC
