Biomedical Devices and Instrumentation Commons^™

A Security Framework For Pacemaker Lead Failure: Anomaly Detection System And Failsafe Policy Considerations, Ethan Wagner

Master's Theses

Embedded system security in implantable medical devices (IMDs) remains an underexplored challenge due to the unique constraints of these systems. Specifically, pacemakers are optimized for ultra-low power consumption to maximize device lifespan, are highly resource constrained, and demand reliable and correct operation to prevent severe health consequences. These systems rely on sensing electrodes, called leads, to detect cardiac activity and stimulate the patient’s heart when appropriate. Therefore, pacemaker lead integrity is a critical issue, as malfunction or compromise can result in device failure jeopardizing patient safety.

The security framework presented in this thesis integrates several works to proactively detect and …

Characteristic Stress And Strain Optimization Of Cardiovascular Catheters With Laser-Cut Hypotubes Using Finite Element Analysis, Kyle E. Hirth

Master's Theses

Cardiovascular catheter systems rely on laser-cut hypotubes to balance flexibility and structural integrity required for minimally invasive surgical procedures.  Optimizing these mechanical characteristics remains a significant challenge.  This study aims to investigate the influence of key laser-cut geometric parameters on the mechanical performance of hypotubes through finite element analysis.

Commercially representative laser-cut hypotubes were modeled and a finite element model was developed.   Geometric design parameters were varied across a design space consisting of pitch values ranging from 0.006 in. to 0.018 in. and cuts per revolution (CPR) ranging from 2.5 – 4.5.  For each pitch and CPR combination, loading stiffness …

Muscle Impulse Transducer: Research, Pre-Pilot Experiments, And The Design Of A Pilot Study For Quadriplegic Spinal Cord Injured Subjects For The Development Of A Novel Device, Marta Oreglia

Master's Theses

Paralysis due to spinal cord injury is a challenging condition that affects millions of people around the world. The Muscle Impulse Transducer (MIT) is a novel, wearable device that can be used to improve grip strength in the hand by using functional muscle impulses as a trigger for stimulus delivery to weakened or paralyzed nerves, to induce contraction of a paralyzed or paretic muscle. The MIT is still in development, with proof of concept [1], and functional prototypes [2] achieved. In this thesis, research was conducted on the best methods for functional electrical stimulation, EMG data collection, and nerve stimulus …

Using Noninvasive Calibrated Cuff Plethysmography To Observe The Effects Of Lifestyle Habits On Arterial Compliance, Joshua M. Whitaker

Master's Theses

Cardiovascular disease remains as a leading cause of death for both sexes and across all racial backgrounds. Continuing to research causes, early predictors, and preventative actions are paramount to ensuring that cardiovascular disease starts to decrease in its activity. Endothelial dysfunction is the earliest known predictor of cardiovascular disease, therefore investigating early detection methods of endothelial dysfunction can improve health outcomes. This study revolves around a non-invasive calibrated cuff device that uses the principles of segmental plethysmography and oscilliometry to measure arterial compliance of baseline and induced hyperemic conditions in human subjects to determine how well arteries vasodilate in response …

Evaluation Of Antibiotic Testing Protocols For Biofilm-Forming Escherichia Coli In A Microfluidic Platform, Caleb R. Telander

Master's Theses

Catheter-associated urinary tract infections remain an ongoing clinical problem due to biofilm persistence and antibiotic resistance. Standard antibiotic susceptibility testing cannot accurately reproduce flow conditions and the spatial complexity of the in vivoenvironment and is thus questionable in relevance to device-related infections. This study examines a microfluidic device designed to simulate physiologically relevant wall shear stress and antibiotic gradients in Escherichia coli biofilms. The polydimethylsiloxane-based system integrates a 16-well culture chamber with a gradient generator. Biofilm growth was observed using fluorescence microscopy of green fluorescent protein-labeled bacteria. Simulations performed using COMSOL Multiphysics software estimated the appropriate range of wall …

Efficacy Of Monophasic And Biphasic Pulsed Field Ablation Waveforms: A Model Study, Natalia Dekock

Master's Theses

Cardiac arrhythmias are conditions where the heart’s normal sinus rhythm is interrupted by accelerated or premature rhythms. The most prevalent of these rhythms is atrial fibrillation (AF), where disorganized impulses cause the atria to quiver and pump blood inefficiently. As of 2025, AF affects over 10 million people. Aside from invasive surgical treatments, antiarrhythmic drugs, or one time cardioversions, atrial fibrillation is treated with catheter ablation. The longstanding ablation solutions for AF have been the cryoballoon or radiofrequency catheter ablation. However, limitations for these two ablation modalities are due to the nature of cell destruction; both thermal methods pose a …

Acoustic And Hemodynamic Analysis Of Phantoms: Roughness And Flow Dynamics, Ethan Erik Olof Sundberg

Master's Theses

The purpose of this study was to determine whether different vascular phantoms, with and without a surrogate arm, could serve as effective analogs to the human brachial artery for assessing endothelial dysfunction, an early indicator of cardiovascular disease, particularly atherosclerosis. Atherosclerosis is characterized by plaque buildup and endothelial damage, which precede more severe clinical events and are often detectable through changes in vascular function. A 40” water tower was used to simulate diastolic pressure, enabling water flow through each phantom. Strain gauge pressure transducers were placed at both ends of the phantoms to measure pressure drop, while a microphone captured …

A Manufacturing Process For Interdigitated Microelectrodes On Glass Wafers, Wyatt W. Warfield

Master's Theses

This study presents work done to optimize the process parameters to produce interdigitated electrodes on a borosilicate wafer. Using designed experiments and statistical analysis, the error in pattern transfer was minimized using for key process steps including exposure time, develop time and post exposure bake duration. Similarly, statistical analysis was used with profilometry data to fine tune the develop times. Qualitative analysis was used to assess thin film deposition. The resulting process produced wafers with improved pattern transfer and adequate film adhesion

Quantifying Harmful Trunk Postures: Inertial Sensor Analysis Of Trunk Angle To Support Low Back Pain Prevention, Elsa E. Bates

Master's Theses

Low back pain is a highly prevalent condition worldwide, impacting up to 80% of individuals at least once in their lifetime. A critical gap in current prevention strategies is the lack of tools to accurately measure trunk posture and movement in real-world environments. Accurate identification of biomechanical risk requires information about movement intensity, duration, and frequency, yet traditional assessment methods rely on self-reporting or visual observation, which are time-consuming and prone to error. To address this gap, a wearable monitoring method, consisting of two Inertial Measurement Units, was designed to quantify risk exposure to the spine by measuring angular position …

Hands-Free Balance Protocol And Development Of An Iphone App For Self-Assessment, Jacob Matties

Master's Theses

For many clinical populations, the measurement of balance is a critical task. Previous studies have agreed that smartphone IMUs provide a valid measure of balance that can be significantly correlated with force plate measurements and is sensitive enough to distinguish between various balance poses, but many balance assessment protocols require uncommon equipment or the use of hands during assessment. These limit accessibility of balance assessment. To eliminate the need for hands or any additional equipment, this study assessed the use of a smartphone recording the root mean square of 3D acceleration magnitude. The goal of the study was to determine …

Development Of A Pressure Sensing System Coupled With Deployable Machine Learning Models For Assessing Residual Limb Fit In Lower Limb Prosthetics, Maxwell D. Lewter

Master's Theses

Lower limb amputations pose significant challenges for patients, with over 150,000 cases annually in the U.S., leading to a high demand for effective prosthetics. However, only 43% of lower limb prosthetic users report satisfaction, primarily due to issues with socket fit, which is critical for comfort, stability, and preventing injury. This study presents a deployable sensing system for potentially real-time monitoring of prosthetic socket fit by using pressure sensors and convolutional neural networks (CNNs) to analyze the pressure distribution within the socket. A novel CNN architecture, utilizing both dilated and strided convolutions, is proposed to effectively capture spatial-temporal patterns in …

Hypoxic Incubator: Improving Robustness/Reliability And Demonstrating Physiological Efficacy, Damon Dennis Tan

Master's Theses

The Microphysiological Systems Laboratory aims to develop colorectal cancer tumor models under a hypoxic environment to assess model response to pharmaceutical compounds in vitro. To perform relevant studies, researchers have attempted to use different hypoxic inducing strategies such as a nitrogen pod and hypoxic incubator to recreate in vivo physiological responses to hypoxia. However, studies would be interrupted due to incubator functionality failure. To ensure successful and physiologically relevant studies, I improved and verified the robustness and reliability of a hypoxic incubator previously designed and manufactured in the lab. Through the testing and iterating design processes, I engineered and implemented …

Dual Base Sige Is-Hbt For Use In Biosensing Applications, Liam Stephen Hayes

Master's Theses

The proposed research is for a novel SiGe-based Ion-Sensitive Dual Hetero-junction Bipolar Transistor (IS-HBT) to be used in both trans-dermal biological sensing as well as Lab-on-Chip (LOC) applications. The end goals for the device designed are two: For one, the research done for this work will be used to substantiate the claims made by Zafar et al. [1] that an HBT-style structure is better suited for biosensing application rather than a conventional Field Effect Transistor (FET) based geometries. Secondly, it provides the final element to be integrated along with a selectivity membrane, as well as with a reverse-iontophoresis system to …

Development Of An Advanced Step Counting Algorithm With Integrated Activity Detection For Free Living Environments, Paige M. Dolan

Master's Theses

Physical activity plays a crucial role in maintaining overall health and reducing the risk of various chronic diseases. Step counting has emerged as a popular method for assessing physical activity levels, given its simplicity and ease of use. However, accurately measuring step counts in free-living environments presents significant challenges, with most activity trackers exhibiting a percent error above 20%. This study aims to address these challenges by creating a machine learning algorithm that leverages activity labels to improve step count accuracy in real-world conditions. Two approaches to balancing data were used: one employed a simpler oversampling technique, while the other …

Thermal Preconditioning Effects On Perforation Propensity Of Transvenous Implantable Cardiac Leads Used For Pacing And Defibrillation, Diane Muff

Master's Theses

Thermal preconditioning to simulate shipping, handling and storage conditions did not affect distal tip stiffness values for permanently implantable cardiac leads used for pacing and defibrillation. Leads that were subjected to extreme temperatures and temperature cycling did not show changes in buckle force values compared with control specimens which were maintained at ambient room conditions. Absolute differences between all measurements were small, generally under 0.05 N and were attributable to measurement variability.

Buckle force values are used to assess the propensity of leads to perforate the heart, a rare but potentially serious complication of implantable pacing and defibrillation systems. Since …

Manufacturing Silicone In-House For The Creation Of Customized Neurovascular Blood Vessel Mimics, Jacob Wilbert Perisho

Master's Theses

The Tissue Engineering Lab at California Polytechnic State University San Luis Obispo focuses on creating tissue-engineered Blood Vessel Mimics (BVMs) designed for the preclinical testing of neurovascular devices. These BVMs are composed of silicone models, representing anatomically accurate neurovasculatures, that are sodded with vascular cell types and then cultivated in bioreactors (which maintain physiologic conditions). These silicone models are currently sourced externally from industry partners, so the primary goal of this thesis was to develop the means and methods for the Tissue Engineering Lab to manufacture silicone models in-house.

The first aim of this thesis was to develop and explore …

Development Of An In Vitro 3-Dimensional Co-Culture Human Colorectal Cancer Model In Microfluidic Devices, Abby Jens

Master's Theses

Colorectal cancer is the second most common cause of cancer-related deaths in the United States, with the relative 5-year survival rate for distant stage cancer being only 14%. The most common treatment for colorectal cancer is with chemotherapeutic drugs; however, the discovery of these drugs is costly, time-consuming, and often requires the use of animal models that do not yield results that translate to clinical trials. Due to these shortcomings, researchers seek to develop physiologically relevant in vitro tumor models that more accurately mimic the tumor microenvironment for cheaper and faster high-throughput drug screening. The aim of this research was …

Development Of A Cell Culture Incubator Capable Of Providing A Hypoxic Environment, Grant Austin Coe

Master's Theses

In order to perform more robust and physiologically relevant research, the Microphysiological Systems laboratory required a method of culturing cells where the level of oxygen could be adjusted. To fulfill this need, I designed and manufactured a hypoxic cell culture incubator. I employed a Quality Function Deployment to understand the customer requirements and convert them into engineering specifications. Based on these specifications, I created various conceptual designs. I evaluated the conceptual designs as compared to existing products and decided to move forward with the control system separated from a small, standard chamber. I developed the circuitry schematics for the temperature …

Finite Element Analysis Of The Bearing Component Of Total Ankle Replacement Implants During The Stance Phase Of Gait, Timothy S. Jain

Master's Theses

Total ankle replacement (TAR) implants are an effective option to restore the range of motion of the ankle joint for arthritic patients. An effective tool for analyzing these implants’ mechanical performance and longevity in-silico is finite element analysis (FEA). ABAQUS FEA was used to statically analyze the von Mises stress and contact pressure on the articulating surface of the bearing component in two newly installed fixed-bearing total ankle replacement implants (the Wright Medical INBONE II and the Exactech Vantage). This bearing component rotates on the talar component to induce primary ankle joint motion of plantarflexion and dorsiflexion. The stress response …

Effects Of Beet Supplements On Cardiovascular Response Using A Noninvasive Blood Pressure Cuff, Nicholas M. Hughes

Master's Theses

A Calibrated Cuff Plethysmography device was built, tested for verification, and used to experiment on human subjects to measure the cardiovascular response of consuming a beet supplement, specifically looking at arterial compliance and pressure-area curves. Each subject was tested four times. A baseline was measured under normal conditions and after five-minute hyperemia conditions. 10 subjects were given 6 ounces of water mixed with either purple Kool-Aid (control), a SuperBeets supplement, or a SuperBeets Sport supplement and after 45 minutes, measurements were taken undergoing normal and hyperemia conditions once more. The verification testing demonstrated the calibration of the device was effectively …

Using Noninvasive Calibrated Cuff Plethysmography To Observe The Effects Of Cold-Water Immersion On Arterial Compliance, Rita M. Grigorian

Master's Theses

As the prevalence of cardiovascular diseases continues to exponentially grow in populations across the globe, the necessity of determining underlying factors, effective methods of diagnoses, and universally available preventive measures also grows. Early detection of endothelial dysfunction, a proven precursor of cardiovascular diseases, can be extremely impactful in encouraging preventative measures and early intervention before medical conditions become chronic. In recent years, ice plunging, a form of cryotherapy involving full body immersion in cold water, has gained popularity within circles of fitness and health practitioners, gaining the interest of people of all backgrounds. Certain parallels observed between the human physiological …

Characterization And Estimation Of Musculoskeletal Pain Using Machine Learning, Boluwatife Faremi

Master's Theses

Traditional scales utilized for recording pain are known to be highly subjective and biased due to inaccuracies in recollecting actual pain intensities. As a result, machine learning (ML) models that are trained using these scores as ground truth are reported to have low performance for objective pain classification because of the huge disparity between what was felt in moments of pain and the scores recorded afterward.

In the present study, two devices were designed for gathering real-time, continuous in-session subjective pain scores and the recording of the autonomic nervous system (ANS) altered endodermal (EDA) activity. 24 participants were recruited to …

Static Vascular Modeling Of Diabetes Progression, Andrea Skattenborg

Master's Theses

Cardiovascular disease is the leading cause of mortality in diabetic patients, and diabetes is one of the main causes of cardiovascular disease. Risk factors for cardiovascular disease result in structural and functional changes in the vascular wall. Arterial stiffness is a prominent structural change observed in the arterial wall that can be measured in clinical settings. The purpose of this thesis was to create a static model of the changes in arterial stiffness seen in diabetes. Elastic tubes with varying wall thicknesses were used to create artificial arteries for this purpose. Compliance (inverse of stiffness) of the arteries was determined …

Analytical Pipeline To Facilitate Electroencephalography Pain State Identification In Patients With Chronic Low Back Pain, Emma Katharina Jacobs

Master's Theses

Chronic low back pain (cLBP) affects the quality of life of over 23% of American adults and places an immense burden on the economy.^1–3 To more effectively diagnose and treat cLBP, quantitative biomarkers are needed to objectively measure pain and better identify the underlying mechanisms of cLBP. The overarching goal of this work is to create an analytical pipeline to investigate brain activity patterns measured with electroencephalogram (EEG) data of cLBP patients treated with transcutaneous spinal cord stimulation (tSCS). The specific aims of this project are to 1) investigate whether there is a difference between baseline EEG measurements and …

Analysis Of Arterial Compliance Using A Surrogate Arm Bench Top Model For The Validation Of Oscillometric Blood Pressure Methods, Christopher J. Cunningham

Master's Theses

A study was performed on a recently developed prototype of the Yong-Geddes surrogate arm design to collect compliance data of the various system components and determine the accuracy of measurements made through the bench top model. The study was performed to perceive the effectiveness of the model as a tool for validating non-invasive blood pressure detection monitors. Three stages of testing were performed to gather pressure and volume data from an artificial artery component, a sphygmomanometer, and the surrogate arm system to produce compliance estimations. Mathematical equations from supported arterial hemodynamics studies and clinical trials were applied to the pressure …

A Proof Of Concept For Detection Of Palato-Lingual Contact Without Intraoral Electrodes In A Human Participant, Amitava Biswas

Master's Theses

The author of this thesis conceived and investigated an unexpected electrical signal that may not be noticed during regular electroglottography (EGG) when electrodes are conventionally placed on the anterior surface of the throat. It appears that there is a measurable electrical signal from the EGG equipment when electrodes are placed over the frontal cheek (belly of zygomatic muscle), and the tongue is elevated to contact the hard palate, or the tongue is lowered to break the contact. Therefore, this phenomenon is designated as unconventional electroglottography (UEGG, Dr. Steven Cloud, private communication, July 17, 2022).

Two distinctive patterns of waveforms were …

Hypoxic Incubation Chamber, Simone Lisette Helfrich, Makenzie Nicole Jones

Master's Theses

This paper describes the design, manufacturing, and testing of a novel controllable hypoxic incubator with fully functional oxygen gas control and temperature control in a humid environment. On the current market, a majority of the few hypoxic incubators use pre-mixed gas that does not offer precise control over gas concentration. The objective for this project was to create a chamber that allows the user to set the O2 concentration to varying set points of % O2 while maintaining the chamber at a constant body temperature, CO2 level, humidity, and sterility. To start the project, multiple concepts were developed for the …

Smart Spine Tape: Active Wearable Posture Monitoring For Prevention Of Low Back Pain And Injury, Samuel J. Borda

Master's Theses

Back pain and injury are a global health issue and are a leading cause of work and activity absence. Prevention would not only save those affected from the burden of pain and discomfort, but would also save people from loss of over 290 million workdays annually and save the healthcare system billions of dollars in expenses per year. Successful research and development of a wearable technology capable of comprehensively monitoring spinal postures that are leading causes of back pain and injury can result in prevention of mild to severe back pain and injury for high-risk people. To accomplish this, the …

Integration Of Electrical Impedance Spectroscopy For Multichannel Cell Culture Measurement, Conard Chan

Master's Theses

ELECTROCHEMICAL IMPEDANCE SPECTROSCOPY (EIS) has been widely used to study the electrical properties of biological material due to its non-invasive nature and experimental reliability. However, most of the precision impedance analyzers used in EIS only provide single- or two-channel measurements which are inadequate for larger-scale multiplexed measurements, such as those found in modern microfluidic cell culture experiments. The Biomedical Microsystems Laboratory has developed a 16-channel cell culture platform with integrated electrode arrays for monitoring cell growth and electrical properties (i.e., the so-called “electrical phenotype”). In this paper, a system consisting of a 16-channel solid-state analog multiplexer (MUX)paired with a low-cost, …

Microfluidic Electrical Impedance Spectroscopy System Automation And Characterization, Keaton Frahmann

Master's Theses

In this work, a novel microfluidic cell culture platform capable of automated electrical impedance measurements and immunofluorescence and brightfield microscopy was developed for further in-vitro cellular research intended to optimize cell culture conditions. The microfluidic system design, fabrication, automation, and design verification testing are described. Electrical and optical measurements of the 16 parallel cell culture chambers were automated via a custom LabView interface. A proposed design change will enable gas diffusion, removing the need for an environmental enclosure and allow long-term cell culture experiments. This "lab on a chip" system miniaturizes and automates experiments improving testing throughput and accuracy while …