EFRI-BioFlex: Hybrid polymer-paper based multi-sensor implants for continuous remote monitoring

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Hydrocephalus is a chronic incurable condition that characterized by the excess accumulation of cerebrospinal fluid in the brain and affects 1 to 2 in every 1000 births per year. Today, hydrocephalus is primarily treated using an implanted shunt to drain excess fluid, a technique that is virtually unchanged since its introduction in the 1950?s. Its temporary efficacy has made hydrocephalus one of the most frequently encountered problems in neurosurgery with repeated shunt revisions or replacements required over the lifetime of a patient. A major unmet need is early diagnosis of shunt malfunction which is difficult, unreliable, and costly. Intellectual Merit:Rapid and accurate diagnoses are critically important to initiate timely intervention and avoid prolonged suffering. Therefore, the overall goal of this proposal is to realize a transformative wirelessly-operated multi-sensor system comprising a self-aware, self-reporting hydrocephalus shunt. Novel concepts will be introduced in materials, sensors, microfabrication, and systems integration to overcome the current limitations and engineering challenges. Flexible substrates will consist of paper selectively integrated into a polymer carrier film that is either directly applied to catheters or seamlessly connected to tissue using selectively patterned and strategically placed thermosensitive bioadhesives. Composite thin film substrates with novel material properties will contain sensors, electronics, and a power source while still allowing conformal placement. Functional initiated chemical vapor deposited polymers will be selectively applied using novel techniques to modify surfaces to minimize immunologic responses and prevent biofouling and infection. Electrodeposited films will be explored as novel sensor materials that are easily integrated with BioFlex. Multi-sensor arrays will feature ?wet? electrochemical impedance transduction technology that does not requiring hermetic packaging. Flexibility and miniature form factor are critical for low profile multi-sensor systems that conform to standard flexible polymer shunts and occupy limited real estate in vivo. This system provides a wireless technology platform for the objective diagnosis of shunt dysfunction and real-time monitoring of hydrocephalus-shunt hydrodynamics to enable better patient care and correlation of treatment to disease progression. The foundation established here will promote long-term growth of BioFlex remote monitoring implants for challenging critical care applications. The technical team brings complementary strengths in biomaterials, surface coatings, modeling and simulation, microelectronics, microelectromechanical systems fabrication and sensors, wireless devices, implantable devices, and system integration to realize transformational bioelectronic implants. Broader Impacts:BioFlex will enable improved care of hydrocephalus, a chronic, incurable disease typically starting at childhood and requiring a lifetime of medical care. Remote monitoring followed by timely intervention will improve care and quality of life while reducing both hospitalizations and healthcare costs. The economic and environmental benefits of the development and use of implantable, wireless BioFlex for hydrocephalus include reduced hospital admissions, earlier interventions, prevention of crisis management, reduced complications, and halting of disease progression. This platform will be the basis for future development of self-aware . The diverse BioFlex team is committed to broadening participation with an extensive track record to prove it. A major focus is recruitment of diverse students for research experiences at all education levels and focused mentoring. Students will amplify outreach as BioFlex ambassadors to recruit future engineers to undergraduate programs. International collaborations will be developed and enriched through undergraduate, graduate, and researcher exchange through existing programs. Partnership with the Center for Technology and Innovation in Pediatrics and Center for Body Computing will promote timely collaboration between students, researchers, clinicians, and industry.