Biomedical Engineering and Bioengineering Commons^™

A Comprehensive Review Of The Food And Drug Administration, The 510(K) Application Process, And Fda Certification For A Diagnostic Device, Taylor Davis

Biomedical Engineering

The company G-Force CRC LLC is currently experiencing the dichotomy of the FDA's conflicting role right now as they begin to approach FDA approval. G-Force CRC LLC is a small medical device company headquartered in San Diego, CA. The owner of the company, Dr. Ian Purcell, is an Otoneurologist apart of Alvarado Hospital. His medical practice mainly deals with patients who have balance disorders and therefore the devices that he has developed over the last 6+ years are primarily used to assist in the diagnosis of those balance disorders. G-Force CRC LLC was officially created in the summer of 2013 …

Self-Contained Breathing Apparatus For Firefighter With A Permanent Stoma, Jason Delgadillo, Aaron Wheeler, Zachary Wishbow

Biomedical Engineering

The purpose of this project was to create a unique SCBA (self-contained breathing apparatus) for a firefighter named Chris Gauer. This prototype consists of a SCBA headgear connected to a polycarbonate-formed stoma mask with a medical-grade sanitary silicone hose.

Smooth Muscle Cell Organization In The Stem Region Of The Gracilis Collateral Circulation In Balb/C Mice, Laura Lenae Burckhardt

Biomedical Engineering

Of the approximately 8 million Americans who suffer from ischemic peripheral arterial occlusive disease (PAOD), many present with intermittent claudication, or pain associated with exercise. Impaired vasodilation of resistance vessels is a potential explanation for this symptom. Occluded arteries can lead to increased flow through collateral vessels, which function as natural bypasses around the obstruction. This increase in blood flow and resulting shear stress can cause outward remodeling, or arteriogenesis, which improves the efficacy of collaterals. However, following femoral artery ligation in a mouse model of chronic ischemia, vasodilation in the stem region of collateral vessels is impaired at day …

Development, Characterization, And Optimization Of Process For Minimal Functional Barrier And Channel Width In Nitrocellulose Paper Microfluidic Diagnostic Platforms, Ryan Daniel Silva

Biomedical Engineering

A central goal of diagnostic microfluidics is to reduce the cost of diagnostic medicine by reducing the equipment and reagents needed to perform diagnostic tests. The literature has demonstrated that a wax printer can be used to pattern nitrocellulose paper with hydrophobic barriers to direct a sample in a defined reaction path, eliminating the need for external pumps and controllers. However, manufacturing methods for minimizing sample volume (and thus reagent volume) in a paper-diagnostic chip have not been well defined. In this work, we experimentally determine manufacturing processes for creating functional features of minimal size—effectively reducing the sample size and …

Microvascular Topology And Intravascular Endothelial Cell Labeling In The Gracilis Anterior Muscle Of Balb/C Mice, Paul Heckler Ii

Biomedical Engineering

Peripheral arterial occlusive disease (PAOD) affects approximately 200 million individuals globally. The major underlying cause of PAOD is an inflammatory disease known as atherosclerosis, which results from the build-up of low-density lipoproteins (LDL) in the sub-intimal space. This initiates a complex cascade of events that lead to plaque growth. Plaque growth can then expand into the lumen of the vessel and result in occlusion and/or thrombosis. Symptoms of the disease can include claudication, ulcers, and/or gangrene, although many patients are asymptomatic. Similar to other forms of ischemic disease, risk factors for PAOD include hypertension, diabetes, and smoking. Common treatments include …

Smooth Muscle Cell Organization In The Stem Region Of The Gracilis Collateral Circulation, Amanda Krall

Biomedical Engineering

Many patients who suffer from the ischemic Peripheral Arterial Occlusive Disease (PAOD) experience intermittent claudication, which can be attributed to impaired vasodilation. Collateral vessels are the primary site of resistance to blood flow downstream; therefore maximizing vasodilation in collaterals is crucial for efficient circulation. Collaterals function as natural bypasses around the occluded arteries and the increase in flow into these vessels causes them to outwardly remodel into conduit vessels. However, functional vasodilation in the stem region of collateral vessels is impaired at day 7 following femoral ligation, which can be attributed to smooth muscle cell malfunction. However, the increase in …

Development And Implementation Of Assessment Methods For Tissue-Engineered Blood Vessel Mimics, Tanner Stevenson

Biomedical Engineering

Coronary Artery Disease (CAD), the most prevalent form of heart disease, is the result of clogged or damaged coronary arteries and claims around 380,000 Americans annually. A common treatment for CAD involves placing a stent into the artery in order to open the lumen and support the native tissue—a procedure that drastically reduces patient recovery times in comparison to heart bypass surgery. However, stents do not always interact well with the body and require additions such as surface coatings or drug elution in order for additional biocompatibility. These additions necessitate extensive in vitro and in vivo testing which are expensive …

Functional Vasodilation Is Impaired In Arterialized Capillaries In The Spinotrapezius, Joshua P. Cutts

Biomedical Engineering

Ischemic diseases are the result of atherosclerotic plaques, which occlude conduit arteries. Ischemic disease in different tissues leads to different conditions, such as coronary artery disease (CHD), cerebrovascular disease (CVD), and peripheral arterial occlusive disease (PAOD). Patient vasculature architecture is variable; some patients having many collateral vessels, which are connect one arterial branch to another, and readily serve as natural bypass routes to atherosclerotic occlusions, to enlarge and provide blood flow to tissue distal to the occlusion. Patients with many natural collateral vessels are ischemia protected. Unfortunately, not all patients have collateral arterioles to remodel into conduit vessels and provide …

Sonar For The Visually Impaired, Anastasia Newark, Edwin Ng, Scott Terhorst

Biomedical Engineering

There are currently no inexpensive assistive devices that allow the visually impaired detect low hanging objects that are above waist height and may cause injury, such as a rope or tree branch. The challenge presented to the team by the Quality of Life Plus Lab (QL+) was to develop a Sonar Cane device that attaches to a traditional white cane to address this problem. This device must be lightweight, inexpensive to manufacture, have a long battery life, and accurately detect obstacles to prevent user injury.

The Effect Of Neurostimulation On Blood Flow And Ischemic Pain, Stacey M. Fishman

Biomedical Engineering

Chronic pain caused by lack of blood flow is known as ischemic pain. Neurostimulation, the application of electrical currents through a region of the body, is effective for pain modulation, and it is hypothesized that this can be explained by the gate control theory and alterations of the sympathetic output initiated by the metaboreflex. The decrease of sympathetic output reduces vasoconstriction and improves blood flow. Transcutaneous electrical nerve stimulation (TENS) and interferential currents (IFC) stimulation, both non-invasive neurostimulation techniques, were evaluated for their effects on cutaneous blood flow on the palm. High or low frequency TENS and/or IFC, and the …

Alternate Computer Input Device For Individuals With Quadriplegia, Tobais Elder, Michelle Martinez, David Sylvester

Biomedical Engineering

This project details the design development of an alternative computer input system that allows a person with quadriplegia to move a computer's cursor and activate left and right click button inputs. After researching and analyzing possible solutions, an end design was chosen that most appropriately satisfied all user requirements and engineering specifications. This final design employs a head mounted Inertial Measurement Unit (IMU) with 9 DoF (Degrees of Freedom) to track head movements and correlate these motions to computer cursor movements. A Sip-Puff Transducer monitors and interprets a user's application of negative and positive air pressure differentials to a vinyl …

A Strategy For Integrating Essential Three-Dimensional Microphysiological Systems Of Human Organs For Realistic Anticancer Drug Screening, Christopher Heylman, Agua Sobrino, Venktesh S. Shirure, Christopher Cw Hughes, Steven C. George

Biomedical Engineering

Cancer is one of the leading causes of morbidity and mortality around the world. Despite some success, traditional anticancer drugs developed to reduce tumor growth face important limitations primarily due to undesirable bone marrow and cardiovascular toxicity. Many drugs fail in clinical development after showing promise in preclinical trials, suggesting that the available in vitro and animal models are poor predictors of drug efficacy and toxicity in humans. Thus, novel models that more accurately mimic the biology of human organs are necessary for high-throughput drug screening. Three-dimensional (3D) microphysiological systems can utilize induced pluripotent stem cell technology, tissue engineering, and …

Modeling And Experimental Methods To Predict Oxygen Distribution In Bone Defects Following Cell Transplantation, Christopher M. Heylman, Sharon Santoso, Melissa D. Krebs, Gerald M. Saidel, Eben Alsberg, George F. Muschler

Biomedical Engineering

We have developed a mathematical model that allows simulation of oxygen distribution in a bone defect as a tool to explore the likely effects of local changes in cell concentration, defect size or geometry, local oxygen delivery with oxygen-generating biomaterials (OGBs), and changes in the rate of oxygen consumption by cells within a defect. Experimental data for the oxygen release rate from an OGB and the oxygen consumption rate of a transplanted cell population are incorporated into the model. With these data, model simulations allow prediction of spatiotemporal oxygen concentration within a given defect and the sensitivity of oxygen tension …

Mechanoadaptation Of Feed Artery Smooth Muscle Cells In The Stem Of The Collateral Circulation, Allison Peck

Biomedical Engineering

Many patients suffering from peripheral arterial occlusive disease (PAOD) experience intermittent claudication, pain during locomotion. Previous studies suggest that this symptom could be explained in part by impaired vasodilation in collateral arteries. In this study, femoral ligation was performed on a murine animal model, stimulating collateral outward remodeling. The mechanism by which a collateral increases its luminal diameter in response to the increase in blood flow following occlusion warrents further investigation due to impaired vasodilation following collateral remodeling. Specifically, resting diameter is elevated in the stem region of the collateral circuit, but this increase in vessel size cannot be explained …

Vascular Reactivity Of Immature Arterialized Capillaries, Sara Hellstrom

Biomedical Engineering

Peripheral arterial occlusive disease (PAOD) is a globally prevalent cardiovascular disease in which atherosclerotic plaques narrow arterial lumen diameters and restrict blood flow to down stream tissues. The impact of these occlusions can be mitigated by collateral vessels that connect parallel arterial branches and act as natural bypasses to maintain perfusion. Some patients with PAOD may not have robust collateral networks to accommodate ischemic tissues in the event of an occlusion and, therefore, may be more susceptible to hypoxia and tissue necrosis. In animal models that lack collateral arterioles, capillaries can arterialize and form functional collaterals; however, in the early …

Guidance System, Kayaking For The Visually Impaired, D. Ryan Kirtland, Ryan Phife, William Gardner, Amy Johnson

Biomedical Engineering

Quality Life Plus is working with Team River Runner to develop an assistive guidance system for veterans who want to remain active by kayaking, after sustaining an injury that impairs vision. This system allows these veterans to complete a slalom speed race independent of a personal guide in the water. The system incorporates 3 stations that each contain a speaker connected to a microcontroller system covered by a Pelican Case on a custom made buoy. During the slalom race, a kayaker will travel from shore towards buoy #1 as it omits sound from the speaker. As the kayaker moves around …

Evaluation Of The Anterior Talofibular And Calcaneofibular Ligament In Relation To Supination Ankle Sprains, Peter Tran

Biomedical Engineering

Ankle injuries have always posed an issue to a number of athletes. Sports that involve running and jumping accumulate about 25% of injuries correlating to ankle sprains. In most ankle sprains the inversion (supination) of the ankle cause damage to lateral ligaments. The two most common lateral ligaments to experience damage are the anterior talofibular (ATFL) and calcaneofibular (CFL) ligaments. The methods of taping and ankle braces have allowed athletes to prevent recurring sprains from occurring. However, sprains can still occur even when one or both methods are applied. The purpose of each method is to restrict the range of …

Shelf Life Study Of Electrospun Plga Copolymers, Sean Youra, Nick Hudson

Biomedical Engineering

Poly(lactic-co-glycolic acid) (PLGA) is one of the most commonly used copolymers for electrospinning in tissue engineering applications. However, most research has not focused on the copolymer itself in regards to how long it can be used effectively and if varying the concentrations of polylactic acid (PLA) and polyglycolic acid (PGA) affect the resulting properties. Electrospinning is the method we use to create the three-dimensional constructs, or “scaffolds”, for the blood vessel mimic (BVM) in the tissue engineering lab. The aim of our project was to investigate if the morphology and mechanical properties of the scaffolds changed over time when they …

Analysis Of Acetabular Cup Orientation Effects On Stress Shielding In Total Hip Replacements Using Finite Element Methods, Brogan Mcguire, Jennifer Gemkow, Brad Gausewitz, Alex Georges

Biomedical Engineering

Improper positioning of the acetabular cup has been shown to contribute to issues such as high wear rates and dislocations in total hip replacements. The differences in contact mechanics due to varying orientation of the acetabular cup may also significantly affect strain distribution in the femur. This study examined these effects of acetabular orientation changes and their contribution to stress shielding using finite element analysis. A solid model of a cementless total hip implant was obtained using 3D point scanning and implanted virtually into a femur solid model. The implanted femur model was imported into ABAQUS and loaded with a …

Effect Of Oral Lipids On Blood Glucose, Tyler R. Knisley

Biomedical Engineering

Diabetes mellitus is a disease in which insulin hormone is ineffective or no longer produced. Multiple pathophysiologies can cause either insulin dependent diabetes mellitus (IDDM) or insulin independent diabetes mellitus (IIDM), which can lead to chronic hyperglycemia and an array of short and long term health risks. Prior research has shown that IDDM patients have dyslipidemia, and experiments infusing lipids directly into the blood result in heightened insulin resistance. The hypothesis that dyslipidemia increases insulin resistance was tested by performing oral glucose tolerance tests across three treatment conditions. Participants were nondiabetic college-aged students. Data from a control group was gathered …

A Mouse Model Of Aortic Endothelial Denudation And Neointimal Formation, Ashkon C. Nehzati

Biomedical Engineering

More than 385,000 people die from coronary heart disease (CHD) annually and treatment costs $108.9 billion each year including the cost of health care services, medications, and lost productivity. CHD decreases heart function by limiting oxygen and nutrient transport carried through the coronary arteries. A complete block to the coronary arteries causes a myocardial infarction in response to an elimination of blood supply to cardiomyocytes. Partial occlusion results in insufficient blood supply to cardiomyocytes, producing myocardial ischemia and angina, which are usually treated with intravascular stents deployed percutaneously, before myocardial infarction occurs. Stents are the most common ways to expand …

Design Of An Experimental Approach To Study The Growth Of Biofilm On Polymethylmethacrylate, Eireen S. Escalona

Biomedical Engineering

Biofilms are present in virtually every solid-liquid contact surface and are partially responsible for some diseases and water cleaning. They are a community of a variety of organisms that live symbiotically and are bound together by extracellular polymeric substances, or EPS. Biofilms go through five stages of development. These include initial and irreversible attachments, maturations I and II, and dispersion. In the dental world, biofilms are often associated with mouth infections including dental caries, gingivitis and periodontitis. Elderly denture wearers are susceptible to the pathogen-causing bacteria associated with these diseases, particularly those who have Alzheimer's disease or other forms of …

Finite Element Analysis Of The Nerve Cuff To Determine Usability And Stress Analysis During Regular Use, Vivek Machhi

Biomedical Engineering

To determine the stress analysis on the Nerve Cuff by MicroProbes, a finite element analysis was conducted. A simplified model was created in Solid Works using the geometry of the basic model of the nerve cuff. The solid model was then imported into Abaqus and the appropriate materials, boundary conditions, and loads were designated. Initially a tensile test simulation was conducted using a tensile force of 2.87 Newtons. The maximum stress experienced with this tensile force was 8.225 MPa which was greater than the ultimate tensile strength of 5.5 MPa of Silicone. Both the actual tensile test and the tensile …

A Microfluidic Pretreatment Isoelectric Focusing Dc-Field Assisted H-Filter For The Separation Of Charged Particles, Cameron Sean Carroll

Biomedical Engineering

Microfluidic devices are small portable diagnostic chips that allow for analysis of a biologic sample at relatively low cost. This makes them ideal for settings where a hospital is unavailable. The microfluidic pretreatment isoelectric focusing DC-field assisted H-filter is a device that allows for the separation of differently charged particles in a biologic sample. It does this by employing the concepts of diffusion, electrophoresis, and isoelectric focusing. This is perfect for isolation of a desired analyte or separation of waste from a sample in order to achieve better diagnostic results. The device was first modeled mathematically and visually using Comsol. …

Investigating The Reproducibility Of The Current Bvm Protocol, Corey Gross

Biomedical Engineering

Coronary Artery Disease (CAD) is responsible for 1 death every minute in the US. Angioplasty with the implantation of stents is a common treatment method for CAD. Although there is a variety of stents currently on the market, there is still a need to develop new types for different pathologic conditions. Preliminary assessment of the physiological response to new stents is needed as they are being developed. The FDA approval process implemented today is a long, tedious path with a range of testing methods that include static in vitro testing and high-cost animal testing. Tissue engineered blood vessels have been …

Biomedical Advancements In Injury Recovery, Performance Enhancement, And Mechanical Assistance Applied To Athletics, Matthew Russell

Biomedical Engineering

Athletics is constantly changing, and athletes are continually getting bigger, faster, and stronger. At the same time, biomedical technology and innovation is rapidly developing. New methods of injury recovery, genetic enhancement, and prosthetic assistance are being assimilated into the athletic world. The up and coming athlete needs to be aware of all of the usable information around them. This project is an accumulation of some of the cutting edge advancements in those fields. Platelet Rich Plasma Injections, Frequency Specific Microcurrent Treatment, and Silk Polymer Anterior Cruciate Ligament Replacement are innovative new ways to treat common sports injuries. Performance enhancement has …

A Biomechanical Comparison Of Three Spondylolysis Repair Techniques In A Calf Spine Model, R. Roberto, B. Dezfuli, C. Deuel, S. Curtiss, S. Hazelwood

Biomedical Engineering

Summary of background data: Previous work has demonstrated the efficacy of lumbar pedicle screw hook rod (PSHR) techniques and the Buck screw in the stabilization of spondylolysis. The mechanical behavior of lower profile cervical implants used to create PSHR, hybrid cable plate constructs, and titanium miniplating has not previously been described.

Methods: Calf lumbar spines (L2-L6) were utilized for testing (n = 27). Intervertebral rotation was measured in the intact spines across the L4-5 segment before and after creation of bilateral pars interarticularis defects. Defects were then stabilized with one of three repair techniques, PSHR, miniplate, or …

Slowing The Onset Of Hypoxia Increases Colony Forming Efficiency Of Connective Tissue Progenitor Cells In Vitro, Christopher M. Heylman, Tonya N. Caralla, Cynthia A. Boehm, Thomas E. Patterson, George F. Muschler

Biomedical Engineering

Background: Survival and colony formation by transplanted tissue derived connective tissue progenitor cells (CTPs) are thought to be important factors in the success of clinical tissue engineering strategies for bone regeneration. Transplantation of cells into defects larger than a few millimeters expose cells to a profoundly hypoxic environment. This study tested the hypothesis that delaying the onset of hypoxia will improve the survival and performance of CTPs in vitro.

Methods: To mimic declines seen in an avascular in vivo bone defect, colony forming efficiency by marrow derived nucleated cells was assessed under osteogenic conditions. Variation in the rate of …

Development Of A Protocol To Measure Gene Expression In The Mouse Tibia, Daniel Hoover

Biomedical Engineering

Numerous molecular factors active in bone tissue direct fracture repair and remodeling which can be altered by disease conditions such as Peripheral Arterial Disease (PAD) and Osteoporosis. Methods of molecular biology are commonly applied to investigate the expression and role of these molecular factors. This project presents a robust three-step protocol for examining gene expression in the mouse tibia. The protocol begins with isolating RNA from a flash frozen tibia sample. The isolated RNA is reverse transcribed into cDNA. Finally, PCR is performed to indentify expressed genes. Establishing this protocol will allow further research into the mechanisms of bone remodeling …

Testing And Validation Of An Autostainer, Nicholas Hanne

Biomedical Engineering

Histology performed by Cal Poly students for research projects and labs are currently performed by hand using a dipping technique. This technique is time consuming, expensive, imprecise, and often unrepeatable. Central Coast Pathology donated a Dako Autostainer to the Biomedical Engineering Department that can perform immunohistological stains of up to 48 samples simultaneously using tightly controlled reagent volumes and incubation times. Protocols are programmed into the machine and can be repeated under the same conditions every time with minimal preparation and exposure to potentially dangerous reagents. The autostainer was repaired and validated by comparing PECAM & BBI stains performed on …