The metabolic panel has emerged as the standard line of inquiry for initial screening as well as follow-up assessment in the healthcare domain. Administered via blood draw in the clinical setting, the metabolic panel consists of assessing 14 unique blood-borne analytes indicative of renal and hepatic function, electrolyte and fluid balance, diabetes mellitus, kidney disease, and hypertension. Despite the clinical utility of the metabolic panel, the process of drawing blood is inconvenient, painful, and can only provide a snapshot of the patient's metabolic function at a particular moment in time, thereby limiting its utility for monitoring chronic conditions. However, in order to be effective, treatment of chronic conditions entails a concerted and proactive effort to manage healthcare throughout the daily routine, which would be substantially enhanced if circulating metabolite and electrolyte levels were able to be quantified on a continuous (rather than intermittent) basis. This project aims to address the above limitations of a conventional metabolic panel via the development of a """"""""Metabolic-Panel-on-A-Chip"""""""". The proposed device leverages our team's latest innovations in electrochemistry, 3D-printing, conducting polymers, and surface functionalization to tender the real-time profile of blood-based electrolytes in a minimally-invasive, pain-free fashion, thereby leading to substantially improved clinical outcomes among the general population as well as those afflicted with chronic disease. Expected outcomes from this research project include: (1) the development of minimally-invasive microneedle arrays containing electrochemical transducers that exhibit chemical selectivity towards sodium, potassium, chloride, and bicarbonate ions and (2) the ability to fabricate the said microneedle arrays employing high-throughput, low- cost 3D-printing methods. This agglomerates innovative techniques for the functionalization of the microneedle contingents and relies on the development of ion-selective membranes in connection with novel methods of electrochemical transduction. The salient features of this transdermal biosensor platform include high sensitivity, stability, selectivity, simplicity, versatility, and robustness at a price that is amenable to widespread healthcare adoption. The proposed microneedle array biosensor will thus fill a long-standing void by enabling the healthcare provider to record, archive, and assess the metabolic response of the patient to the administration of various medical treatments, medications, and therapies, resulting in improved management of chronic disease.

Public Health Relevance

The proposed project aims to develop minimally-invasive 3D-printed microneedle array biosensors for the transdermal quantification of electrolyte levels (sodium, potassium, chloride, and bicarbonate). This new paradigm will impart the ability to monitor electrolytes in a real-time, continuous, and pain-free fashion to assess fluid and electrolyte status, kidney function, and response to various medications and other medical therapies. The proposed research will substantially advance the state-of-the-art in the extraction of pertinent physiological information from the skin without requiring venipuncture blood draws, and will circumvent many of the challenges associated with the performance of conventional metabolic panels that are widely used in the clinical setting.

Agency
National Institute of Health (NIH)
Institute
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Type
Small Business Innovation Research Grants (SBIR) - Phase I (R43)
Project #
1R43DK103559-01
Application #
8779957
Study Section
Special Emphasis Panel (ZRG1)
Program Officer
Arreaza-Rubin, Guillermo
Project Start
2014-08-01
Project End
2016-07-31
Budget Start
2014-08-01
Budget End
2015-07-31
Support Year
1
Fiscal Year
2014
Total Cost
Indirect Cost
Name
Electrozyme, LLC
Department
Type
DUNS #
City
Encinitas
State
CA
Country
United States
Zip Code
92024