SBIR-STTR Award

Wearable Noninvasive Blood Alcohol Monitor
Award last edited on: 11/22/2017

Sponsored Program
SBIR
Awarding Agency
NIH : NIAAA
Total Award Amount
$1,483,174
Award Phase
2
Solicitation Topic Code
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Principal Investigator
Michael T Carter

Company Information

KWJ Engineering Inc

8430 Central Avenue Suite C
Newark, CA 94560
   (510) 794-4296
   sales@kwjengineering.com
   www.kwjengineering.com
Location: Multiple
Congr. District: 17
County: Alameda

Phase I

Contract Number: 1R43AA024651-01
Start Date: 9/10/2015    Completed: 2/29/2016
Phase I year
2015
Phase I Amount
$148,584
?The overall goal of the Phase I program will be to provide proof of feasibility for a new, unobtrusive wrist band style blood alcohol sensor. The device will continuously measure blood alcohol content (BAC) by noninvasive detection of transdermal alcohol content (TAC) using an ultralow power (microwatt), tiny, printed gas sensor recently developed in our company. The wrist band will also provide several key physiological measurements (temperature, local skin humidity, position/activity and heart rate detection) in addition to BAC. This device will prove beneficial in clinical and research settings, alcohol treatment programs, the criminal justice system and public safety. Capitalizing on the recent trend toward public demand for wearable technology for health monitoring, the wristband will also be attractive to individuals who wish to use it for health and activity tracking. The vast majority of alcohol monitoring performed today is done in support of court-ordered alcohol treatment, for example in DUI cases. The ankle monitors used here are bulky, obtrusive and can interfere with the performance of daily routine activities. The goal of this program is to develop new wrist band style monitor that is smaller, nonintrusive, comfortable and more appealing to the wearer. This will facilitate treatment compliance and will make the product more appealing to the mass market, for example, in voluntary health and fitness sectors. The technical strategy for Phase I will focus on the fabrication and validation of the ultralow power printed alcohol sensor for measurement of transdermal alcohol and incorporation of the sensor and supporting electronics into a wristband sized package. Selected supporting physiological sensors will be identified and tested along with the alcohol sensor in a benchtop alpha prototype in Phase I. The system will provide BAC, physiological data, wireless data transmission to smart phone/web-based health systems, and will be able to self-calibrate and indicate out of calibration status. The device will be removable and able to operate for up to a year on a single coin cell battery. The Phase I program will provide a clear path to full prototype development and testing in Phase II. This device will provide societal benefits by improved compliance in alcohol abuse treatment, facilitation of public safety, new avenues to long term studies and knowledge in research and clinical settings, and improved general health. Economic benefits will accrue from job creation to provide the new technology and reduced healthcare costs related to alcohol abuse.

Public Health Relevance Statement:


Public Health Relevance:
This program will develop a new, noninvasive blood alcohol monitor in the form of wrist band. The device will be small, comfortable and compatible with routine daily activities. This device will prove beneficial in clinical and research settings, alcool treatment programs, the criminal justice system and public safety and will capitalize on the recent trend toward public demand for wearable technology for health monitoring.

NIH Spending Category:
Alcoholism, Alcohol Use and Health; Behavioral and Social Science; Bioengineering; Mental Health; Substance Abuse

Project Terms:
Absenteeism; Abstinence; Alcohol abuse; alcohol abuse therapy; Alcohol consumption; alcohol content; Alcohol dependence; alcohol measurement; alcohol monitoring; Alcohol withdrawal syndrome; alcohol-related death; Alcoholism; alcoholism prevention; Alcohols; Ankle; assault; Awareness; base; Blood; Blood alcohol level measurement; Calibration; Caregivers; Cause of Death; Cells; Cellular Phone; Centers for Disease Control and Prevention (U.S.); Chronic Disease; Clinical; Clinical Research; cloud based; Coin; Communication; Compliance behavior; cost; court; Crime; Criminal Justice; Data; data exchange; design; Detection; Development; Devices; Diagnosis; Disease; Domestic Violence; Economics; Electronics; Environment; experience; fitness; Gases; Goals; handheld mobile device; Health; Health Care Costs; Health system; Health Technology; Heart Rate; Homicide; Humidity; improved; Individual; Injury; Knowledge; Legal; Life Style; light (weight); Longitudinal Studies; Maintenance; Marketing; Measurement; Measures; Medical; miniaturize; Monitor; Motion; new technology; Occupations; Online Systems; Patients; Pattern; Performance; Persons; Phase; Physiological; Positioning Attribute; Printing; problem drinker; Process; programs; prototype; public health relevance; Recovery; Relapse; Reporting; Research; Safety; Sampling; Secure; sensor; Skin; social; Statistical Study; success; Suicide; Sweat; System; Technology; Temperature; Testing; therapy design; Time; treatment program; trend; Validation; Vision; Wireless Technology; Withdrawal Symptom; Workplace; Wrist

Phase II

Contract Number: 2R44AA024651-02
Start Date: 00/00/00    Completed: 00/00/00
Phase II year
2017
(last award dollars: 2018)
Phase II Amount
$1,334,590

The goal of this proposed NIH SBIR Phase II program will be to continue development and commercialization of a new noninvasive transdermal alcohol monitor. The monitor will be in wristband or watch form, similar to a smartwatch. This device will be modern, attractive and comfortable and will have smartwatch features including measuring key physiological parameters (e.g., pulse) with wireless communication to apps on smartphones and other devices. The aim of the work is to provide a new, noninvasive transdermal alcohol monitor into the market. The transdermal alcohol monitoring market has few wearable products available and innovation has been lacking in this field. This new product will take advantage of current trends in wearable technology. As the public becomes more comfortable with wearables, the blood alcohol monitor will become popular with people interested in health and fitness who want to track their alcohol intake. The product will provide a new, highly reliable and sensitive method for tracking blood alcohol which will eventually be adopted in other areas, including clinical and medical treatment and employee wellness programs. The device is expected also to provide a more effective system than is currently available for alcohol research. The monitor is based on the KWJ Engineering’s printed electrochemical gas sensor. This ethanol sensor is very small, ultralow power and highly sensitive with very low interferences. These characteristics provide a sensor that is more effective than those used in current technologies. Additionally, because of its size and power requirements, it is the only gas sensor available that is compatible with modern applications such as the watch format of this proposal. In Phase I, we demonstrated stable and sensitive measurement of ethanol across human skin surrogate membranes with a first prototype wristwatch device that included the ethanol sensor and circuitry for performing the measurement and converting data for wireless communication to a computer. Raw transdermal ethanol concentrations (TAC) were calibrated to blood alcohol values using standardized ethanol solutions as a surrogate for blood alcohol concentration (BAC). We demonstrated a high degree of reproducibility across several watch format devices. In Phase II, development of the device will be continued in collaboration with partners specializing in wearable systems and product development. A small human trial will be conducted to evaluate the wearability and functionality of the Phase II prototype device.

Public Health Relevance Statement:
Project Narrative This NIH SBIR Phase II proposal addresses development of a new, noninvasive wrist-mounted device for measuring blood alcohol. This wristwatch platform with modern smartwatch capabilities will move the state of innovation forward in the noninvasive alcohol monitoring field and will contribute societal benefits in the form of facilitation of alcohol research and treatment with additional benefits in opening up blood alcohol monitoring to consumers interested in health and fitness, employer wellness programs and other medical and judicial system uses.

Project Terms:
Abstinence; Address; Adopted; alcohol abuse therapy; alcohol availability; Alcohol consumption; alcohol measurement; alcohol monitoring; alcohol research; Alcohols; Area; base; Blood; Blood alcohol level measurement; Cellular Phone; Characteristics; Clinical; Clinical Treatment; Collaborations; commercialization; Communication; Computers; court; Criminal Justice; Data; Development; Device or Instrument Development; Devices; Employee; Engineering; Ethanol; fitness; Gases; Generations; Goals; Health; Human; improved; innovation; interest; Justice; Lead; Measurement; Measures; Medical; Medical Research; Membrane; Methods; Modernization; Monitor; North Carolina; offender; operation; parole; Performance; Phase; Physiologic pulse; Physiological; probation; product development; programs; prototype; Reproducibility; Research; research and development; sensor; Skin; Small Business Innovation Research Grant; Standardization; System; Systems Development; Technology; Testing; trend; United States National Institutes of Health; Universities; Validation; wearable technology; Wellness Program; Wireless Technology; Work; Wrist