SBIR-STTR Award

Wearable sensor for opioids detection based on electrochemical sensor array integrated with Bluetooth device In this Phase I project, we will develop the prototype of a wearable device, as a forearm bracelet, for rapid, on-site opioid intake monitoring and alerting. We will demonstrate the feasibility of this approach by fabricating an electrochemical sensor array, sweat stimulator, and flexible printed circuit board, integrated all in one microchip capable of opioids detecting in human sweat with ultra-high sensitivity (ng/L range) and enhanced selectivity. To provide an ultra-high sensitivity, a nanoporous silicon membrane will be employed as a substrate for the working electrode. Additionally, advancements of the proposed approach include a high level of integration of all functional modules in one microchip, low cost and maintenance through long-term durability, low power consumption, and cost-effective production. The proposed Phase I project has three Aims: "¢ Aim 1: Develop a prototype of the sensory wearable device, which comprises: (i) an electrochemical sensor array tuned to two target opioids and integrated with (ii) a sweat stimulator, (iii) flexible printed circuit board and (iv) Bluetooth transceiver; "¢ Aim 2: Demonstrate that the prototype is capable of opioid detecting with ultra- high sensitivity (within ng/L range) and high selectivity/low cross-reactivity; "¢ Aim 3: Investigate the correlation between prototype sensitivity/specificity and human parameters (age, gender) with the assistance of drug treatment center in Fall River, MA. In Phase II the prototype of the wearable device will be further optimized and developed to the level of commercial readiness. Major objectives of Phase II include: wireless communication with user interface (smartphone, computer), increasing the number of sensors in the array to other opioids (mostly synthetic), improvement of sensitivity (down to low ng/L range) cross-reactivity and long-term stability, business plan preparation, patent filing and establishing contacts with end-users, purchasers and venture groups so that product commercialization can be started after Phase II.

Public Health Relevance Statement:
Project Narrative The goal of this proposal is to develop a wearable device, as a forearm bracelet, for rapid, on-site opioids intake monitoring and wireless alerting. We will demonstrate the feasibility of this approach by fabricating an electrochemical sensor array, sweat stimulator, and flexible printed circuit board, integrated all in one microchip that is capable of detecting opioids in the human sweat with high sensitivity and selectivity, has long-term durability, and can be manufactured cost-effectively. This new sensing platform will overcome the limitations of current methods of opioids detection employing sweat collection and its analysis at lab facilities.

Project Terms:
falls; Businesses; Family member; base; sensor; Site; Area; Phase; Opiates; Opioid; Rivers; Diagnostic; Sensory; Techniques; membrane structure; Membrane; biological sensor; Biosensor; Devices; Reporting; cross reactivity; microchip; Cell Phone; Cellular Telephone; iPhone; smart phone; smartphone; Cellular Phone; Provider; Preparedness; Readiness; Address; Drug Abuse Treatment Centers; Drug Treatment Centers; Drug Rehabilitation Centers; Detection; Collection; wireless; Wireless Technology; Monitor; Preparation; Molecular; developmental; Development; cost; new approaches; novel approaches; novel strategy; novel strategies; cost effective; Consumption; innovate; innovative; innovation; imprint; prototype; commercialization; bio-markers; biologic marker; biomarker; Biological Markers; flexible; flexibility; opiate use disorder; opioid use disorder; opiate consumption; opiate drug use; opiate intake; opiate use; opioid consumption; opioid drug use; opioid intake; opioid use; opiate crisis; opioid crisis; opioid epidemic; Bluetooth; body sensor; body worn sensor; wearable sensor; wearable system; wireless sensor technology; wearable sensor technology; wearable electronics; wearable technology; wearable device; Nanoporous; wireless communication; printed circuit board; Age; ages; Chlorine; Cl element; Computers; Disease; Disorder; Pharmaceutical Preparations; Drugs; Medication; Pharmaceutic Preparations; drug/agent; Electrodes; Electrolytes; Fentanyl; Actiq; Duragesic; Fentanest; Fentyl; Phentanyl; Forearm; Glucose; D-Glucose; Dextrose; Goals; Health; Human; Modern Man; Maintenance; Methods; Morphine; Infumorph; Kadian; MS Contin; MSir; Morphia; Oramorph; Oramorph SR; Roxanol; Statex SR; Legal patent; Patents; Patients; Production; Public Health; Research; Safety; Sensitivity and Specificity; Signal Transduction; Cell Communication and Signaling; Cell Signaling; Intracellular Communication and Signaling; Signal Transduction Systems; Signaling; biological signal transduction; Silicon; Si element; Sodium; Na element; Specificity; Technology; United States; Gender; Drug Monitoring

Wearable sensor for opioids detection based on electrochemical sensor array integrated with Bluetooth device In this Phase II project, we will develop a new electrochemical sensor array with ultra- high sensitivity (ng/mL limit of detection), enhanced drug specificity, long-term durability, low power consumption, and cost-effective production. By the end of Phase II, 20 devices (along with 42 sensory cartridges for each) will be produced and ready for commercialization (TRL 9) upon completion of Phase II. To provide an ultra-high sensitivity, nanoporous silicon will be employed as a substrate for the working electrode. Additionally, advancements of the approach include a high level of integration of all functional modules on one microchip, wireless communication with user interface (smartphone, computer), low cost and maintenance through long-term durability, low power consumption, and cost-effective production. The specific aims of Phase II are as follows: "¢ Develop a prototype of the sensory wearable device, which comprises an electrochemical sensor array tuned to six target opioids and six non-opioid narcotics "¢ Demonstrate that the prototype is capable of narcotic detection with ultra-high sensitivity (within ng/L range) and high selectivity/low cross-reactivity "¢ By the end of Phase II, produce 20 devices (TRL 9) ready for commercialization In Phase II, the prototype of the wearable device will be further optimized and developed to the level of commercial readiness. Major objectives of Phase II include optimization of individual sensors to the lowest limit of detection and fabrication of two interchangeable sensory cartridges for six opioids and six non-opioid narcotics; integration of the sensory module with the printed circuit board for data conditioning, processing, and wireless transmittance; two-level trials with human subjects; submission of an FDA application; fabrication of 20 devices and cartridges ready for commercialization (TRL 9); patent filing; and establishing contacts with end-users, purchasers and venture groups so that product commercialization can be started after Phase II (we will use the company profit for sales and marketing).

Public Health Relevance Statement:
Project Narrative The goal of this Phase II proposal is to develop a commercially viable wearable device as a forearm bracelet, for rapid, on-site testing for opioids and other narcotics with wireless alerts. We demonstrated the feasibility of this approach in Phase I. The Phase II effort will focus on further development and optimization to provide ultra-high sensitivity (ng/mL detection range), enhanced drug specificity, long-term durability, low power consumption, and cost-effective production. Upon completion of Phase II, 20 devices will have been produced and will be ready for commercialization.

Project Terms:
Antibodies; Chlorine; Cl element; Computers; Heroin; Diacetylmorphine; Diamorphine; Pharmaceutical Preparations; Drugs; Medication; Pharmaceutic Preparations; drug/agent; Electrodes; Electrolytes; Fentanyl; Actiq; Duragesic; Fentanest; Fentyl; Phentanyl; Forearm; Glucose; D-Glucose; Dextrose; Goals; Health; Human; Modern Man; Immobilization; orthopedic freezing; Maintenance; Manuals; Marketing; Methods; Morphine; Infumorph; Kadian; MS Contin; MSir; Morphia; Oramorph; Oramorph SR; Roxanol; Statex SR; Narcotics; Patents; Legal patent; Patients; Production; Public Health; Scientific Publication; Publications; Safety; Sales; Sensitivity and Specificity; Cell Communication and Signaling; Cell Signaling; Intracellular Communication and Signaling; Signal Transduction Systems; Signaling; biological signal transduction; Signal Transduction; Si element; Silicon; Na element; Sodium; Specificity; Technology; Testing; United States; Drug Monitoring; Illicit Drugs; Family member; base; human subject; sensor; Site; Area; Surface; Phase; Individual; Opiates; Opioid; non-narcotic analgesic; non-opiate analgesic; non-opioid; non-opioid therapeutics; nonnarcotic analgesics; nonopiate analgesic; nonopioid; nonopioid analgesics; non-opioid analgesic; Funding; Comment; Commentary; Editorial Comment; Viewpoint; Published Comment; Sensory; Source; biological sensor; Biosensor; sensory integration; Devices; cross reactivity; microchip; computer chip; Cell Phone; Cellular Telephone; iPhone; smart phone; smartphone; Cellular Phone; Provider; Preparedness; Readiness; Address; Data; Detection; Intake; Small Business Innovation Research Grant; SBIR; Small Business Innovation Research; Monitor; Preparation; Development; developmental; cost; conditioning; novel strategies; new approaches; novel approaches; novel strategy; cost effective; Consumption; innovation; innovate; innovative; prototype; commercialization; Biological Markers; bio-markers; biologic marker; biomarker; opioid use disorder; opiate use disorder; opioid epidemic; opiate crisis; opioid crisis; Bluetooth; wearable sensor technology; body sensor; body worn sensor; wearable biosensor; wearable sensor; wearable system; wearable device; wearable electronics; wearable technology; Nanoporous; wireless communication; printed circuit board; detection limit; disease diagnostic; wireless