Begell House Inc.
Critical Reviews™ in Biomedical Engineering
CRB
0278-940X
47
2
2019
Preface: Sensors for Advanced Manufacturing, Wearables, and Point-of-Care Devices in La Belle Labs at Arizona State University
v-vii
10.1615/CritRevBiomedEng.2019028311
Chi-En
Lin
School of Biological and Health Systems Engineering, Arizona State University, Tempe, Arizona
Jeffrey
La Belle
Arizona State University
point-of-care sensing
advanced manufacturing
wearable devices
electrochemical impedance spectroscopy
rapid prototyping
health monitoring
Currently, ASU is home to more than 100,000 students at four campus, West, Polytechnic, Main Campus in Tempe and Phoenix Downtown and it hosts the largest engineering school in the country with over 22,000 students! Arizona State University is a microcosm of Arizona in terms of diversity from just about every metric, very representative place as well as innovative place.
Since we are very innovative and do things at scale, we have assembled a very large lab (also known as the La Belle Labs) at ASU, sometimes as many as 80+ members, more typically around 40+. The labs themselves are split into 2 physical locations, one is a 2,000 sq ft machine shop space with modern manufacturing equipment from CNC, laser cutting, 3D printing (SLA, FDM, etc), as well as my blacksmithing gear (a side hobby). The wet lab space is about 1,800 sq ft of space with screen printing, ELISA, electrochemical stations, among other standard lab equipment.
BODDEE BUDDEE: Evaluation of Different Foams and Thermoplastics to Develop a Biofidelic Manikin for Cardiopulmonary Resuscitation
101-108
10.1615/CritRevBiomedEng.2019026286
Alex
Walsh
School of Biological and Health Systems Engineering, Arizona State University, Tempe, Arizona
Kathryn
Douglass
School of Biological and Health Systems Engineering, Arizona State University, Tempe, Arizona
Jeffrey
La Belle
Arizona State University
CPR
manikin
CPR manikin
BLS
BLS training
Cardiopulmonary resuscitation (CPR) is an emergency course of action developed to sustain oxygenated blood flow in persons suffering from cardiac arrest by manually compressing the heart in the chest and providing rescue
ventilations. The best-selling CPR manikins, an integral part of training, are costly investments that lack biofidelic characteristics in appearance, feel, and response; as a result, the rescuer's learning experience suffers. The objective of the present study was to test the compressibility properties of different foams and thermoplastics in order to determine which material would most accurately imitate a human chest response. The results suggested that styrene-ethylene/butylene-styrene (SEBS) was the best choice, because its increasing stiffness under increasing compression was characteristic of a human chest cavity. Further testing must be done to determine the best composition of SEBS, analyze its response under cyclic compressions, and improve its durability.
A Comparison of Force Sensing for Applications in Prosthetic Haptic Feedback
109-119
10.1615/CritRevBiomedEng.2019026514
Megan
Wieser
School of Biological and Health Systems Engineering, Arizona State University, Tempe, Arizona
Jinglin
Liu
School of Biological and Health Systems Engineering, Arizona State University, Tempe, Arizona
Priscilla
Hernandez
School of Biological and Health Systems Engineering, Arizona State University, Tempe, Arizona
Jeffrey
La Belle
Arizona State University
capacitive load cell
conductive polyurethane
electrochemistry
cyclic voltammetry
amperometric scan
The current study presents a comparison of two load sensor designs that can be applied toward haptic feedback sensing in upper limb prosthetics. A lab-standard capacitive load cell sensor is discussed, which is succeeded by the
proposal of an electrochemical sensor. Experiments were conducted primarily as a proof-of-principle study to evaluate sensor characteristics for prosthetic applications. The aim is to address the need for minimally invasive, cost-effective prosthetic sensor technologies, as the investigated sensor designs conceptualize applications of average grip forces. Thus, force requirements for the sensors were determined to be 250–500 N per the average maximum grip strength of healthy adults. Comparable to a commercial gold-standard capacitive load cell design, a lab-standard load cell sensor was inexpensively manufactured using conductive foam. The lab-standard design was improved upon by employing electrochemical techniques and CP-9000, a thermoplastic elastomer material, to form an electrochemical sensor for enhanced sensitivity. Sustained loads ranging from 0.49 to 2.45 N resulted in average maximum current readouts of − 1.25 × 10-1 to − 4.25 × 10-1 for the lab-standard sensor, and − 5.95 μ;A to − 7.85 μ;A for the electrochemical sensor. The electrochemical sensor was reproducible and demonstrated the potential to discriminate between various loads. Force requirements were not reached; however, future studies will seek to increase the mechanical strength of the electrochemical sensor. As the initial electrochemical sensor design provides a potential method for low-cost computer-based prosthetics, thermoplastic elastomer materials with increased elastic and mechanical strength properties will be investigated.
Staggered Nitinol Wire Actuator Array for High Linear Displacement and Force-to-Mass Ratio
121-129
10.1615/CritRevBiomedEng.2019026515
Katelyn
Conrad
School of Biological and Health Systems Engineering, Arizona State University, Tempe, AZ 85287-9709
James
Choca
School for Engineering of Matter, Transport, and Energy, Arizona State University, Tempe, AZ 85287
Steven
Lathers
School of Biological and Health Systems Engineering, Arizona State University, Tempe, AZ 85287-9709
Jeffrey
La Belle
Arizona State University
actuator
nitinol
biomimicry
staggered array
prosthetic
shape memory alloy
We present the design and performance of a unique Nitinol (NiTi) actuator design for high linear displacement
and force generation through joule heating. The device is comprised of a staggered linear array of NiTi in wire form
that, as a shape memory alloy, can achieve linear displacement through material phase change when heated. This change allows the crystal lattice within the material to displace/adjust. The design results in strain levels of 20.4% that are comparable to those of biological muscles and provides potential for additional strain. Three- to seven-staggered NiTi wires are tested to demonstrate the different levels of strain that are achieved with a range of wires in a staggered array. In addition, we measure and compare force generated to the mass of each wire to show system force-to-mass ratio. The effective force to mass for the system is greater than 5500 combined with a seven-wire staggered array. The device shows that a lightweight, high-strain actuator can be developed, and our research demonstrates its potential use in prosthetic actuation.
Toward the Development of a Wearable Optical Respiratory Sensor for Real-Time Use
131-139
10.1615/CritRevBiomedEng.2019026605
Alejo
Chavez-Gaxiola
School of Biological and Health Systems Engineering, Arizona State University, Tempe, AZ 85287
Zachary
Fisher
School of Biological and Health Systems Engineering, Arizona State University, Tempe, AZ 85287
Jeffrey
La Belle
Arizona State University
respiration rate
wearable sensors
digital image correlation
Respiration rate is an important vital sign that can provide insight into a patient's status and health progression.
This information is used from critical care to sports and human performance evaluation. The current state of the art has demonstrated effectiveness in monitoring respiration rate with the use of wearable sensors. However, their form factor, which refers to the embodiment of approach, size, and shape, makes it difficult to implement within a longterm monitoring setting. Problems relating to form factor, such as compliance, are a major issue in collecting useful and
actionable data, because they directly impact comfort and ease of wear. We present a new approach based on an optical
computer mouse sensor that can be rendered into a slim, wearable device without the need for a harness or shirt to hold the sensor in place. Its main objective is to achieve similar or better readings than those of the state of the art while reducing the overall size and thus, improve compliance by making it easier, more comfortable to wear. The principle of operation of the sensor allows for enhanced signal and computational noise reduction for movement artifacts. The sensor was tested to determine its limits of detection and was calibrated to expected distance of movement. Then, observations were made under normal breathing conditions, apnea, deep breathing, and hyperventilation covering a spectrum of 0 to 45 breathings per minute (BPM). The performance of the device was described by using the mean average error which was 0.37 and 0.83 under deep breathing and hyperventilation, respectively. Testing revealed that the device produces the
best results when worn over the diaphragm and that its readings are comparable to the industry gold standard. The future version we are developing incorporates a slimmer, lighter design, Bluetooth data communication to remove leads and wires, adhesive electrodes and a reusable adhesive that is also waterproof.
Non-Contact Type Pulse Oximeter
141-151
10.1615/CritRevBiomedEng.2019026539
Anirudh Nandakumar
Joshi
School of Biological and Health Systems Engineering, Arizona State University, Tempe, AZ, 85287, United States
Amy L.
Nystrom
School of Biological and Health Systems Engineering, Arizona State University, Tempe, AZ, 85287, United States
Jeffrey
La Belle
Arizona State University
miniaturization
noninvasive health monitoring
noncontact
pulse oximetry
wearable sensors
heart rate
Heart rate and through-body blood perfusion are vital measurements in all stages of patient care, be it predictive, in the clinical setting, or outpatient monitoring. Irregular, underachieving, or overperforming heart rate is the main precursor of most cardiovascular diseases that have severe long-term complications. In addition to heart rate, the shape of the pulse waveforms can indicate the heart's valve health and electrophysiology health. The goal of the study was to design a noninvasive device for continuously measuring a patient's heart rate with clinical-grade accuracy along with the ability to indicate pulse waveforms for the patient and physician. An accurate, easy-to-use heart-rate measuring device
prototype was developed that did not require the sensor to have direct skin contact to obtain measurements. The statistical analysis of the data gathered by the prototype compared to the data collected from the industry standard device indicated significant correlation. The two-sample T-test for the data recorded from the prototype and the data collected from the industry commercially available pulse oximeter showed a P-value of 0.521, which indicates that there was no significant difference between the prototype and the commercially available pulse oximeter when measuring heart rate.
Proof of Concept for a Universal Identification System for Medical Devices
153-158
10.1615/CritRevBiomedEng.2019026534
Courtney
Mason
School of Biological and Health Systems Engineering, Arizona State University, Tempe, Arizona
Benjamin
Erlick
Mayo Clinic Arizona, School of Medicine Scottsdale, Arizona
Jeffrey
La Belle
Arizona State University
universal identification
barcode
medical devices
X-ray fluorescence
Medical devices need a unified way of accessing information that uniquely identifies them. This can provide traceability to specifications, lot numbers, recalls, and the like. Such a system would have applications for devices both in and out of the body. Common barcodes, such as a UPC code, can only be read in plain sight, when nothing comes between the scanner and the code. UPC coding is not suitable for all medical devices because some are implanted in the body or are otherwise inaccessible without invasive techniques. This article demonstrates a proof of concept for XRF coding on devices. Material codes were made and read externally by an XRF reader. The reading showed trace amounts of the chemicals that compose the medical device in the background signal. The energy levels of the chemicals were assigned values to build a readable code correlated with information about the medical device it is attached to. Attachment
can be made during material synthesis, part or product manufacture, or even after final assembly. The technique demonstrated here is a promising concept for the future of medical device detection.
Feasibility of Commercially Marketed Health Devices for Potential Clinical Application
159-167
10.1615/CritRevBiomedEng.2019026110
Kevin D.
Uchimura
School of Biological and Health Systems Engineering, Arizona State University, Tempe, AZ, 85287
Teagan L.
Adamson
School of Biological and Health Systems Engineering, Arizona State University, Tempe, AZ, 85287
Kara M.
Karaniuk
School of Biological and Health Systems Engineering, Arizona State University, Tempe, AZ, 85287
Mark L.
Spano
School of Biological and Health Systems Engineering, Arizona State University, Tempe, AZ, 85287
Jeffrey
La Belle
Arizona State University
fitness devices
mHealth
quantified self
readmission
wearable sensors
Concerns have been raised regarding the lack of validation on consumer-marketed health-monitoring devices.
An investigation to characterize current health monitoring devices was carried out in the laboratory using widely
accepted clinical and industry criteria. In total, 16 unique devices were examined. These devices were assessed according
to their sensing modalities: step count, blood pressure, body temperature, electrocardiogram, blood oxygen saturation, and respiratory rate. Devices were tested at rest and immediately following exercise. Our results revealed that only four devices meet target requirements for accuracy. The AliveCor, a portable ECG monitor, accurately detected the heart rate for 87% of all recordings. To meet the target criterion for accuracy, the heart rate must be within ± 5 beats/minute or
10% of the standard measurement, whichever is lower. The Withings Pulse Ox, the Tinké, and the Santamedical SM-110
measured blood oxygen saturation with 2.1, 2.6, and 1.4 root-mean-square (rms) error, respectively. For blood oxygen
saturation, the device should demonstrate rms error of < 3%. However, the Withings Pulse Ox and the Tinké failed to meet the accuracy criteria for their alternative biosensing capabilities: step count and respiratory rate, respectively. We conclude that the use of consumer-marketed health-monitoring devices for clinical or medical purposes should be undertaken with caution, especially in the absence of FDA or comparable clearance.
Development Toward a Triple-Marker Biosensor for Diagnosing Cardiovascular Disease
169-178
10.1615/CritRevBiomedEng.2019026532
Anna
Deng
School of Biological and Health Systems Engineering, Arizona State University, Tempe, Arizona
Daniel
Matloff
School of Biological and Health Systems Engineering, Arizona State University, Tempe, Arizona
Chi-En
Lin
School of Biological and Health Systems Engineering, Arizona State University, Tempe, Arizona
David
Probst
School of Biological and Health Systems Engineering, Arizona State University, Tempe, Arizona
Theresa
Broniak
School of Biological and Health Systems Engineering, Arizona State University, Tempe, Arizona
Maryam
Alsuwailem
School of Biological and Health Systems Engineering, Arizona State University, Tempe, Arizona
Jeffrey
La Belle
Arizona State University
cardiovascular disease
electrochemical impedance spectroscopy
optimal frequency
biomarkers
multi-marker biosensor
imaginary impedance
Cardiovascular disease (CVD) is the leading cause of death in the United States and is responsible for 30% of all deaths globally. The diagnosis and management of CVD requires monitoring of multiple biomarkers, which
comprehensively represents the state of the disease. However, many assays for cardiac biomarkers today are complicated and laborious to perform. Rapid and sensitive biosensors capable of giving accurate measurements of vital cardiac biomarkers without complex procedures are thus in high demand. In the work presented below, rapid, label-free biosensor prototypes for three Food and Drug Administration–approved biomarkers are reported: B-type natriuretic peptide (BNP), cardiac troponin I (cTnI), and C-reactive protein (CRP). The sensors were prepared by immobilizing each biomarker's antibody onto gold working electrodes with platinum counter and silver/silver chloride reference electrodes. The sensors were tested using electrochemical impedance spectroscopy (EIS), a femto-molar sensitive technique capable of label-free, multi-marker detection if a biomarker's optimal frequency (OF) can be identified. The OFs of BNP, cTnI, and CRP were found to be 1.74, 37.56, and 253.9 Hz, respectively. The performance of the BNP biosensor was also evaluated in blood and achieved clinically relevant detection limits of 100 pg/mL.