Biomedical Devices and Instrumentation Commons^™

Analysis Of Particles Thorough The Aortic Arch During Transcatheter Aortic Valve Replacement, Andrew Joseph Janicki

Master's Theses

Ischemia caused by particles becoming dislodged during transcatheter aortic valve replacement (TAVR) is a possible complication of TAVR. The particles that become dislodged can travel out of the aortic valve, into the aortic arch, and then into either the brachiocephalic artery, the left common carotid artery, the left subclavian artery or continue into the descending aorta. If the particles continue into the descending aorta it poses no risk of causing ischemia however if it travels into the other arteries then it increases the possibility of the particle causing an ischemic event. The goal of this study is to determine what …

Design And Fabrication Techniques Of Devices For Embedded Power Active Contact Lens, Errol Heradio Leon

Master's Theses

This thesis designed and fabricated various devices that were interfaced to an IC for an active contact lens that notifies the user of an event by detection of an external wireless signal. The contact lens consisted of an embedded antenna providing communication with a 2.4GHz system, as well as inductive charging at an operating frequency of 13.56 MHz. The lens utilized a CBC005 5µAh thin film battery by Cymbet and a manufactured graphene super capacitor as a power source. The custom integrated circuit (IC) was designed using the On Semiconductor CMOS C5 0.6 µm process to manage …

Sapien3 Comb Stitch Improvement For Edwards Lifesciences, William Harley, Thomas Pluschkell, John Mctigue, Garrett Reed

Mechanical Engineering

The complete senior project report was submitted to the project advisor and sponsor. The results of this project are of a confidential nature and will not be published at this time.

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 …

Renal Artery Stent Fatigue Test, Braden Cooper, Munir Eltal, Jennifer Hawthorne, Ashley Schaefer

Mechanical Engineering

In today’s world of medical innovation, regulations and requirements set by organizations such as the Food and Drug Administration (FDA), the International Organization for Standardization (ISO), and ASTM International (American Society for Testing and Materials) can inhibit rapid innovation by demanding rigorous testing of new designs. For arterial stents, the standard is that each design must be tested to simulate 10 years of life in an environment congruent to an in vivo environment. Endologix in Irvine, California develops and manufactures minimally invasive treatments for aortic diseases, with a focus on stent grafts for the treatment of abdominal aortic aneurysms (AAA). …

Heart Valve Leaflet Deflection Testing Apparatus, Brandon Cunnane, Andrew Krasts, Jackson Kunz, Steven Warnert

Mechanical Engineering

The information contained in this report is confidential and proprietary information of Edwards Lifesciences.

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.

Evaluating The Effectiveness Of Cranial Molding For Treatment Of Positional Plagiocephaly Using Finite Element Analysis, Maziyar Keshtgar

Master's Theses

Since the advent of recommendations for placing infants in the supine position during sleep to reduce the incidence of sudden infant death syndrome, clinicians have noted an increase in the frequency of cranial asymmetry due to deformation of suture sections of the infants’ skulls as a result of constant concentrated stress in one area at the back of their head. This specific form of cranial deformation is known as positional plagiocephaly and its rate of occurrence has increased from 0.3% in 8.2% within the past 30 years.

Current treatments and methodologies for preventing and correcting positional plagiocephaly such as stretching …

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 …

Design, Characterization And Application Of A Multiple Input Stethoscope Apparatus, Spencer Geng Wong

Master's Theses

For this project, the design, implementation, characterization, calibration and possible applications of a multiple transducer stethoscope apparatus were investigated. The multi-transducer sensor array design consists of five standard stethoscope diaphragms mounted to a rigid frame for a-priori knowledge of their relative spatial locations in the x-y plane, with compliant z-direction positioning to ensure good contact and pressure against the subject’s skin for reliable acoustic coupling. When this apparatus is properly placed on the body, it can digitally capture the same important body sounds investigated with standard acoustic stethoscopes; especially heart sounds. Acoustic signal inputs from each diaphragm are converted to …

Design And Validation Of A Wearable, Continuous, And Non-Invasive Hydration Monitor That Uses Ultrasonic Pulses To Detect Changes In Tissue Hydration Status, Zoie Engman

Master's Theses

Chronic dehydration is an endemic problem for many population groups. Current methods of monitoring hydration status are invasive, time consuming, cannot be performed while exercising, and require lab resources. A proposed solution is a wearable, continuous, and non-invasive device that uses harm-free ultrasonic pulses to detect changes in tissue hydration status over time. Customer and engineering requirements were defined and used to guide the design process. Literature reviews were performed to identify essential information on dehydration, assess current methods, discover state of the art devices, and describe ultrasonic theory. Market research was performed to identify athletes as the target population …

Team Omnimouse, Derek J. Halman, Josh B. Porter, Steven A. Silver, Ian S. Stemper

Computer Engineering

INFORMATION, DATA, FIGURES AND DRAWINGS EMBODIED IN THIS DOCUMENT ARE STRICTLY CONFIDENTIAL AND ARE SUPPLIED ON THE UNDERSTANDING THAT THEY WILL NOT BE DISCLOSED TO THIRD PARTIES WITHOUT THE PRIOR WRITTEN CONSENT OF QUALITY OF LIFE PLUS.

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.

Design Of Controlled Environment For Tissue Engineering, Malcolm Gerald Lapera

Master's Theses

Design of Controlled Environment for Tissue Engineering

Malcolm Lapera

Tissue engineering aims at relieving the need for donor tissue and organs by developing a process of creating viable tissues in the laboratory setting. With over 120,000 people awaiting a transplant, the need for generating tissue engineered organs is very large [3]. In order for organs to be engineered, a few issues need to be overcome. A work space that both creates an environment which maintains cell viability over an extended period of time as well as accommodates the necessary fabrication equipment will be needed to further tissue engineering research. Therefore, …

St. Jude Medical: Pulmonary Edema Monitoring In Pacemakers And Icds, David Wei-Péng Chang

Master's Theses

Pulmonary edema occurs when fluid leaks from the pulmonary capillary network into the lung interstitium and alveoli. When the heart is not able to pump blood to the body efficiently, fluid can back up into the veins that take blood through the lungs to the left atrium. This then builds up the pressure in the blood vessels and fluid is pushed into the alveoli in the lungs. The fluid reduces normal oxygen movement through the lungs and can cause impaired gas exchange and respiratory failure. There are many causes of congestive heart failure that may lead to pulmonary edema such …

Formulation Development Of A Polymer-Drug Matrix With A Controlled Release Profile For The Treatment Of Glaucoma, Eric W. Tsoi

Master's Theses

Glaucoma is the leading cause of blindness in the United States accounting for 9-12% of all cases of blindness. Currently, the front line treatment for glaucoma are prostaglandins that may have to be taken up to several times a day. Even with proper treatment, roughly 11% of the patients using the treatment are non-compliant and lose their vision. In this project, ForSight Laboratories has developed a pharmaceutical drug delivering implant with the capability of sustaining long-term release of a prostaglandin as a new way to treat the condition. This project reports the product development of a polymer drug matrix with …

Surgical Tooling Designed For The Direct Anterior Approach To Total Hip Arthroplasty, Jon-Peter Meckel

Master's Theses

Surgical Tooling Designed for the Direct Anterior Approach to Total Hip Arthroplasty Jon-Peter Meckel

Total hip arthroplasty (THA) is becoming more and more common in the US as people continue to live longer and more active lives. The main reason that a THA is required is due to the “wear and tear” affliction of osteoarthritis, which in the year 2000 had at least 3% of the population over 30 showing symptoms. A revitalized approach to THA is the direct anterior approach, or Smith-Petersen approach, which limits the amount of musculature affected by the surgery and creates a very stable joint …

The Fabrication & Characterization Of An Electrokinetic Microfluidic Pump From Su-8, A Negative Epoxy-Based Photoresist, Nash Anderson

Master's Theses

Microfluidics refers to manipulation, precise control, and behavior of fluids at the micro and nanoliter scales. It has entered the realm of science as a way to precisely measure or mix small amounts of fluid to perform highly controlled reactions. Glass and polydimethylsiloxane (PDMS) are common materials used to create microfluidic devices; however, glass is difficult to process and PDMS is relatively hydrophobic. In this study, SU-8, an epoxy based (negative) photoresist was used to create various electrokinetic microfluidic chips. SU-8 is commonly used in microelectromechanical design. Spin coating of various SU-8 formulations allows for 1 μm to 100 μm …

Evaluation Of Corrosion Properties Of Proprietary Metal Alloy Stents For In-Vivo Use, Michael David Bremner

Materials Engineering

To assess corrosion rates of metal alloy bio-absorbable stents an experimental set-up was designed to mimic the coronary artery environment. The artery was modeled using 4mm diameter Tecoflex tubing and the metal alloy stents were inserted into the tubing using a catheter. As is the case in cardiac surgery, the catheter with the stent and a microballoon were maneuvered to the desired position. The microballoon was then slowly inflated to expand the stent and compress it against the tubing walls. The catheter and microballoon were then withdrawn. A circulating pump system was set up to cycle fetal bovine serum (FBS) …

Edwards Lifesciences - Skirt To Frame Attachment Manufacturing Aid, Samuel Joda, Cesar Grimaldo, Patrick Hutchinson

Mechanical Engineering

No abstract provided.

Tracking Points On A Pacing Lead In A Beating Heart, Avinash Ramesh Varma

Master's Theses

Heart failure is a common condition during which the pumping action of the heart is affected because the heart does not contract or relax properly. Heart failure affects about 5 million Americans, with 550,000 new cases diagnosed each year. Cardiac resynchronization therapy (CRT) is used to treat symptoms and other complications associated with a heart failure. While performing CRT, Implantation of a pacing lead in the left ventricle of the heart is a very challenging surgical procedure performed with fluoroscopy. The target location is often difficult to reach through the tortuous coronary venous anatomy, which varies greatly among individuals. Placement …

Stent Graft Blush, Vanessa Barrett, Thomas Matzinger, Mike Morelli

Mechanical Engineering

In order to better understand Type IV endoleaks (“blush”), the Cal Poly Senior Project team GraftTest has developed a blush evaluation system able to mimic several of the aorta’s environmental parameters. Capable of both pressure and flow rate control, this bench top system accommodates Medtronic’s wide range of abdominal and thoracic aortic stent grafts. Having researched endoleaks, stent grafts, and numerous other factors affecting stent graft blush, a system was developed with the aim of assessing and comparing the performance of Medtronic’s stent grafts with regard to blush. Furthermore, this system has been designed to provide reliable and repeatable results …

The Effect Of A Triphasic Pulse On Scs To Icd Crosstalk, Ryan James Wensley

Master's Theses

It is a known problem that a Spinal Cord Stimulator (SCS) can interact with an Implantable Cardioverter Defibrillator (ICD) when both devices are implanted in the same patient. Interactions between the SCS and ICD can cause inappropriate therapy which can be harmful to the patient. While ICD devices have a distinct narrowband sensing bandwidth, the pulse configurations that current SCS devices deliver were not designed with this frequency region in mind. In this thesis, I recommend a new pulse configuration for SCS devices that will minimize the interaction between the two devices. I produce a theoretical equation for each pulse …

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 …

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 And Development Of A Stair Ascension Assistive Device For Transfemoral Amputees, Casey Michael Barbarino

Master's Theses

Transfemoral amputees around the world experience increased difficulty in climbing stairs due to lack of muscle, balance, and other factors. The loss of a lower limb greatly diminishes the amount of natural force generation provided that is necessary to propel oneself up stairs. This study investigated possible solutions to the problem of stair ascension for transfemoral amputees by the means of designing and developing an externally attachable device to a prosthesis. The number of amputations from military service has greatly increased since 2008, which shows there is a clear need for assistive devices (Wenke, Krueger, & Ficke, 2012). With the …

Modeling The Zimmer Fitmore And Ml Taper Implantation, Tyler Kazuo Franklin

Master's Theses

With more young adults requiring total hip

arthroplasties the need for bone saving implants becomes

more important. The Zimmer Fitmore is a new bone saving

implant that utilizes an implantation technique that

reduces the damage to the muscle tissue allowing for

patients to have a short recovery time as well as a new

design that allows it to rest on the medial cortex. There

has been anecdotal evidence that this device leads to early

revision within six months of implantation due to failures

occurring in the medial cortex. The main goal of this

study was to computationally model the Zimmer …

Novel Approach To Junctional Bleeding: Tourniquet Device Proposal For Battlefield Hemorrhage Control, Kyle W. Cabaniss

Master's Theses

This study investigated possible solutions to the current wartime problem of junctional hemorrhaging, or massive traumatic hemorrhaging in non-tourinquetable areas such as the neck, groin, or armpit. Junctional hemorrhaging has been identified as a major contributor to potentially survivable deaths seen on the battlefield today and therefore is a priority for the U.S. armed and coalition forces (Kragh et al., 2011a; Bozeman, 2011). Common tourniquets today are standard issue and carried by soldiers in the military, but are limited to distal extremity trauma. As the battlefield has changes however, trauma has transformed from commonly seen gunshot wounds to more extreme …

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. …

Measuring Impedance Of Tissues Using A Microfabricated Microelectrode Array, Ashwini Bhat

Master's Theses

MEASURING IMPEDANCE OF TISSUES USING A MICROFABRICATED MICROELECTRODE ARRAY By Ashwini Bhat

This thesis looks at the possibility of using impedance spectroscopy for differentiating tissue, using a microelectrode array (MEA). The thesis first discusses the background and the motivation for this thesis. It covers the certain basic concepts of the human skin starting from the top epidermis layer all the way to the deep dermis layers of the skin. Then it discusses different types of skin cancer and how they occur, in humans. It also discusses various microfabrication techniques such as oxidation, wet etching, sputtering and photolithography for the creation …