Vanderbilt University

Department of Biomedical Engineering

Senior Design Project

NCIIA Grant Proposal for a Pacemaker Detection Protocol for MR Suites

6 December 2012

“The Coil Kids”

Zach EagletonJosh Shannon

Michael ShannonJosh StewartSam Walling

Abstract: The radio frequency currents produced by MR scanners pose a serious risk for patients with implantable metallic objects, especially pacemakers. Many of the adverse events that result from inadvertent scans of patients with pacemakers could be avoided by proper screening protocol. In response to this need, the aim of this project is provide a protocol to reliably detect the presence of a pacemaker implanted in the patient before beginning the MR scan. The most important objectives of this project are:

To develop a detection device sensitive to implanted pacemakers that can be used to screen patients prior to a scan

To develop a tissue phantom to evaluate the accuracy and efficiency of this detector

To create a protocol to be utilized by radiology technicians that employs the aforementioned detector and reliably ensures that no patient with a pacemaker undergoes an MR scan

Introduction

While artificial cardiac pacemakers have certainly enhanced the quality of life of millions

of individuals, they also subject these individuals to certain adverse effects. MR scanners pose a

serious risk for this population because the strong electromagnetic fields associated with the

radio frequency currents produced by the scanner disrupt the pacemaker’s electric impulses and

render it ineffective or detrimental to the health of the patient. According to the FDA’s

Manufacturer and User Facility Device Experience (MAUDE) Database, the magnetic gradients

of the scan in one case undesirably caused a pacemaker to reduce its pacing rate from 75 to 35

beats per minute and in another, the gradients caused a pacemaker to reset completely and stop

pacing the patient’s heart. These adverse events are caused by the induction of current in the

circuitry of the pacemaker, which alters the device’s function. Additionally, patients have been

internally burned by the induction of electrical current in the pacemaker’s metallic leads.

In response to these life-threatening implications, hospitals have devised individual

protocols to prevent patients with pacemakers from undergoing MR scans. These safety

protocols, however, are highly subject to human error. In most hospitals, including the

Vanderbilt University Medical Center, screening is accomplished solely by a paper

questionnaire, which relies on patients to self-report that they have an implanted pacemaker.

Additionally, a small number of independent companies have developed a market in

ferromagnetic detectors specifically for MR suites. However, these detectors are not sensitive

enough to reliably detect pacemakers and other implantations. As is evident from the incident

reports present in the MAUDE Database, in many cases, the present protocols have not

prevented affected patients from being scanned. It is obvious that more stringent safety

protocols are necessary to prevent these harmful events.

This need to reliably detect pacemakers could be met with many distinct solutions,

including a detailed pre-scan review of the patient’s medical history to crosscheck for history of

a pacemaker implantation or a pre-scan physical exam of the patient’s chest to check for the

presence of a pacemaker. More technologically advanced solutions could also include sensing

the pacemaker’s integrated radio frequency signals, which are used for programming, or using an

electrocardiogram to identify the distinct patterns of a pacemaker in the electrical potential of the

heart. While each of these solutions could be used to meet the present need, we propose that the

most efficacious and promising method involves the development of a metal detection system

capable of detecting a pacemaker implanted inside a human body and a systematic protocol that

employs this detector to ensure no patients with pacemakers are unknowingly scanned. This

detector would be a handheld device that uses alternating magnetic fields to detect the presence

of metal. It would be utilized by the radiology staff during the pre-scan procedure, and if a

pacemaker was detected, the staff would report the finding to a radiologist for further instruction.

History and Context

Accidents related to MR scanners and pacemakers have been on the rise in recent years

as a result of the increasing prevalence of pacemakers in the general population, but still, many

incidents go unreported. According to one study, as of 2004, ten deaths had occurred as a result

of adverse effects of MR scanning on patients with pacemakers (Martin et al, 2004). While there

is little reliable data concerning the incidence of non-mortal consequences, much concern has

been raised in the medical community. Regardless, much of this problem is due to discrepancies

in hospital protocol on screening, as current laws do not require a metal detector test for patients.

This leaves many patients with pacemakers unscreened before entering the machine which poses

severe harm to their health. In our efforts to address this problem, we have discussed possible

solutions with radiologists and biomedical engineers and as a group, have decided to focus on the

device and protocols that we propose here. Attached is a sketch of the device that we currently

envision. Upon completion of a prototype, we hope to form a relationship with the Vanderbilt

University Medical Center to test our protocol in a clinical setting.

Our Team

Our team was created with the goal of taking five intelligent, but different individuals,

and putting them in an environment where their strengths could be maximized. For example,

Zach has had over two years of hands on experience working in a hospital. His understanding of

hospital dynamics will prove vital in creating a device that will be well managed and properly

used in a hospital setting. Mike’s experience with programming will provide technical support

to a team in need of programming savvy engineers. Josh Shannon has great technical skill

having worked in a research lab for over two years. The analytical thinking often employed in

such research will help nail down specific functionalities of our device. Good communication

skills will likely play a role in facilitating progress. Josh Stewart has held positions in the past

where his success was dependent on his ability to communicate effectively. Lastly, Sam’s

leadership has been noted on this project guiding the innovation and brainstorming process.

Furthermore, he has gone through the patenting process multiple times having a greater

understanding of the cost-benefit analysis examined when looking at new devices.

Dr. Will Grissom is our primary advisor and with his expertise in MRI and

electromagnetics, he will be able to guide us through the entire design process. While Dr.

Grissom is our advisor, it will be important in the ensuing months to speak with radiologists and

radiology technicians to give us further insight into the problem.

Work Plan

In order to attain a solution to the needs of this project within the present time constraints,

it is necessary to establish an overall work plan to ensure that progress is being made at an

appropriate pace. As is seen in the Gantt chart in Appendix A, the initial two months of the

project will be spent on the ideation and planning stages of the project. In October and

November 2012, the problem will be identified and the needs declared, which will allow us to

brainstorm possible solutions. In November and early December 2012, these solutions will be

narrowed down to a single design approach. With this design in mind, the appropriate parts and

supplies will be ordered and procured. Once the necessary components are in place, an initial

prototype will be produced by the end of January 2013, which will be modified as necessary

until a final product is developed by the beginning of April 2013. Simultaneously, a tissue

phantom will be produced for testing purposes under the same timeline as above. With this work

plan, milestones will be reached when the ideation process brings us to a single solution

(December 2012), a prototype is developed for both the detector and phantom (January 2013),

and the final design of the detector is implemented (April 2013). By the end of this period, we

expect to have a commercially marketable product that could be used in any radiology clinic to

detect the presence of metal. Because this system approaches the problem at hand in a novel

fashion, its commercial implications could allow the project to continue if MR manufacturers

express interest in incorporating this technology into their scanning systems. Because of the

novelty of our approach and its simplicity in implementation and use, its prospect of attaining

commercial success seems very high.

Evaluation and Sustainability Plan

The first step in developing a device to detect the presence of a pacemaker would be to

first design it so that it would be sensitive enough to detect some aspect of the pacemaker,

whether it be the wires or the main body of the pacemaker. The pacemaker has to be able to be

accurately detected by the device. The ability to develop a prototype that is sensitive enough to

accomplish this is an optimal first measure of the initial success of the device. After this is done,

the next step would be to implant a pacemaker or an object that adequately mimics a pacemaker

into an anthropomorphic tissue phantom to test the ability of the device to detect a pacemaker

while it is implanted. The development of a tissue phantom that sufficiently mimics the area that

the pacemaker will be implanted is the next criteria for success since a well-made phantom will

ensure that the device can accurately detect the pacemaker under the skin. At this point, the

device may have to undergo several iterations of prototyping to reach the desired level of

accuracy. The next measure of success would be when the device reaches the necessary

sensitivity level to detect the pacemaker inside the phantom. After this is accomplished, the

device could then be used on actual people to see how well it can detect the presence of

pacemakers. When the device reaches the capability to detect pacemakers in people at sufficient

accuracy, then this will be the point at which we know that we have succeeded in the design of

the device.

Appendix A.

Works Cited

Martin, Edward T., James A. Coman, Frank G. Shellock, Christopher C. Pulling, Robert Fair,

and Kim Jenkins. "Magnetic Resonance Imaging and Cardiac Pacemaker Safety at 1.5-

Tesla." Journal of the American College of Cardiology 43.7 (2004): 1315-324.

ZACHARY EAGLETONCurrent Address zachary.e.eagleton@vanderbilt.edu Permanent Address 444 Elmington Avenue 217-494-7097 1605 Claude Drive Apt. 536 Springfield, IL 62704 Nashville, TN 37205 EDUCATION Vanderbilt University, School of Engineering Nashville, TN Bachelor of Engineering May 2013 Major: Biomedical Engineering GPA: 3.10/4.00 Dean’s List: Spring 2012 EXPERIENCE Vanderbilt School of Engineering Nashville, TN May, 2012 - Present Research Assistant • Contribute to development of low-resource diagnostic assay for malaria. • Apply Optimal Coherence Tomography to characterize flow profiles in colloids. • Model evaporation of water droplet using COMSOL. • Acquire lab techniques and characterization skills such as fluorescence microscopy, macro writing, and Dynamic Light Scattering.

Memorial Medical Center Springfield, IL May - August, 2010-2011 Emergency Room Unit Support Assistant • Performed EKGs, collected specimens, obtained vital signs, stocked rooms, transported patients, and carried out a variety of necessary ER tasks. • Assisted nurses with patient care and completed regular rounding on rooms to ensure quality patient experience. • Communicated patient needs effectively and accurately to 20 nurses and 5 physicians in a 50 bed, level 1 trauma center.

Franklin Middle School Springfield, IL August, 2010-2012 Basketball Camp Coach Led teams of 15 middle school students in exercises which taught fundamental basketball skills and teamwork.

Southern Illinois University School of Medicine Springfield, IL May - August, 2008-2009 Research Assistant • Assisted with study that sought to determine correlation between REM sleep and chronic obstructive pulmonary disease in patients with sleep apnea. • Collected and analyzed data from polysomnographs and spirometry tests.

VOLUNTEER SERVICE Vanderbilt Student Volunteers for Science Nashville, TN September - April, 2010-Present Team Leader • Organize a small group of volunteers to teach a weekly science lesson to students in Nashville area middle schools.

PROFESSIONAL SKILLS

• Proficient in MATLAB, PowerPoint, Excel, Mathematica, ImageJ, ImagePro, and COMSOL.

Joshua ShannonCurrent Address: joshua.m.shannon@vanderbilt.edu Permanent Address:Vanderbilt University, PMB 343924 (352)410-1741 5092 Mentmore Ave.Nashville, TN 37235 Spring Hill, FL 34606

Education Vanderbilt University, Nashville, TNMajor: Bachelor of Engineering in Biomedical Engineering May 2013Current GPA: 3.4/4.0

Honors/Activities - Dean’s List - Alpha Lamba Delta Honor Society, Phi Eta Sigma Honor Society, National Society of Collegiate Scholars,

Biomedical Engineering Society, Lotus EatersResearch - Vanderbilt University, Advanced Therapeutics Laboratory

Use RAFT polymerization to synthesize stimuli sensitive polymers for intracellular delivery of biomacromolecular drugs.

Apply several methods to purify polymers including precipitation, dialyzing, and lyophilization Characterize polymers using GPC, TEM, DLS and by analyzing GPC and NMR graphs Applied cell culture techniques to grow fibroblast and stem cells Presented and discussed selected research journals and collaborated across engineering disciplines

- Dr. Pintauro’s Lab: The Development of New Proton Exchange Membranes for Fuel Cells Characterized polymers using a Differential Scanning Calorimeter machine and x-ray diffraction Learned the processes of annealing and testing the solubility of polymer membranes

Publications- Nelson CE, Gupta MK, Adolph EJ, Shannon JM, Guelcher SA, Duvall CL. Sustained local delivery of

siRNA from an injectable scaffold. Biomaterials, 33 (2012), pp. 1154-1161

- "Biodegradable Tissue Scaffolds for Cell and siRNA Delivery" BMES Conference poster presentation, Hartford, Connecticut, October 2011.

Leadership - Vanderbilt University, Vanderbilt Students Volunteering for Science Leader Lead a team of five undergraduates in weekly visits to local middle schools to promote an early

interest in science careers through an expanded curriculum and unique learning experiences Create age appropriate experiments to teach hands-on learning and science fundamentals

- Vanderbilt University, V-Squared Mentor

Mentor five first year undergraduate engineers Help acclimate mentees to university life, aid in coursework selection, and provide other guidance

- Vanderbilt University, Biomedical Engineering Society Community Service Committee

Organize and manage several engineering related community service events involving 20-30 volunteers

Research, make initial contacts, and coordinate volunteer events with non-profit organizations

- BMEpulse Journalist

Write several articles for the BMEpulse, an engineering newsletter read by hundreds of undergraduates, professors, and alumni

Made contacts, performed interviews, and summarized seminars with professors and alumni

Michael ShannonCurrent Address: michael.j.shannon@vanderbilt.edu Permanent Address:Vanderbilt University, PMB 355011 (352)410-1641 5092 Mentmore Ave.Nashville, TN 37235 Spring Hill, FL 34606

Education Vanderbilt University, Nashville, TNMajor: Bachelor of Engineering in Biomedical Engineering May 2013Current GPA: 3.55/4.00

Honors/Activities - Dean’s List - Alpha Lamba Delta Honor Society, Phi Eta Sigma Honor Society, National Society of Collegiate Scholars,

Biomedical Engineering Society, Lotus Eaters Honor SocietyResearch - Vanderbilt University, Biomedical Modeling Laboratory

Use a biomechanical model to work towards image guidance for breast surgery Acquire data from tissue phantom using such equipment as a laser range scanner (LRS) and a CT

scanner Become familiarized with the basics of an image guidance system Use Matlab to analyze data gathered from LRS, CT scan, and a volume mesh to generate a model

with boundary conditions that can be used to predict deformation Use a finite element model to simulate a retraction on a tissue phantom Received SPIE Honorable Mention Award for poster presented on research First author on paper published in SPIE Conference proceedings

- Vanderbilt University, Baudenbacher Lab: Design of a Nano-Liter Bioreactor for the Detection of Norepinephrine

Develop a microelectrode and a master of a nano-liter bioreactor on a silicon wafer using standard photolithography devices and techniques

Work in ISO5 clean rooms for photolithography and microfabrication of devices Perform cyclic voltammetry measurements of norepinephrine concentrations using an iridium oxide

microelectrode Trained student on proper protocol for working in clean room and performing appropriate

photolithography techniques for the design of a nano-liter bioreactor

Service - Vanderbilt University, Global Medical Brigades

Work in a resource poor setting to provide medical relief for impoverished families Shadow local doctors and help provide medications to patients Overcame language barriers to educate patients and children on personal hygiene

- Vanderbilt University, Engineering World Health

Build and test electrosurgery unit (ESU) testers to give to developing country hospitals and to ensure the functionality of these devices

Part of design team to develop a cost effective and reliable infant respiratory monitor to be used in resource-poor hospitals

Skills - Programming Languages: Matlab (2 years including 1 year of in lab experience), C++, Java

Joshua StewartHome Address: joshua.m.stewart@vanderbilt.edu School Address: 9 Revolutionary Road c: 978-844-4038 411 Village at VanderbiltActon, MA 01720 Nashville, TN 37212

Education

Vanderbilt University, Nashville, TN Bachelor of Engineering, Biomedical EngineeringMinor: MathematicsGPA: 3.0Spring 2013

Colby College, Waterville, Maine2009-2010

Relevant Courses

Tissue Engineering, Analysis of Biomedical Data, Computer Programming, Biomechanics, Biomedical Materials, Linear Algebra and Differential Equations, Circuits, Biomedical Instrumentation, Statistics and Probability, Vector Calculus, Systems Physiology, Physical Transport Phenomena

Relevant Work Experience

Sung Laboratory, Vanderbilt UniversityResearch Assistant (Winter 2012-Present)

Synthesis and characterization of a vascular patch programmed for shape memory function and reactive oxygen species (ROS) degradation

Allen Medical Systems - subsidiary of Hill-Rom, Acton, MAIntern (Summer 2011)

Helped design a modern “Jackson” spinal table for surgery

Volunteer ExperienceAlternative Spring Break, Talladega, AL (Spring 2012)James Eldridge, Democrat for Massachusetts State Senate Seat, Acton, MA (Summer 2008)Relief Missions, Compassion for Hope, Jamaica, Gulfport, MS (Summers 2007-2009)

Campus Involvement

Vice President, Vanderbilt Health and Fitness Club (2011-present)Team Leader, Vanderbilt Student Volunteers for Science (2011-present)Member, Vanderbilt Biomedical Engineering Society (2010-present)Teammate, Colby College Water polo Team (2009-2010)

Proficiencies/Skills

MATLAB, Mathematica, STATA, Logger Pro, Sage, some Solidworks, Microsoft Office products: Excel, Power Point, and Word

Professional Membership

Biomedical Engineering Society – Student member

SAMUEL CLINTON WALLINGCurrent Address: 502.424.0703 (C)PMB #355714 502.897.3040 (H)2301 Vanderbilt Place samuel.c.walling@vanderbilt.eduNashville, TN 37235-5714

EDUCATION

Vanderbilt University, School of Engineering, Nashville, TN Bachelor of Biomedical Engineering, May 2013

Saint Xavier High School, Louisville, KYHigh School Diploma, May 2009GPA: 4.00/4.00 (unweighted) 5.09/4.00 (weighted)Honors: National Merit Scholar, Outstanding Leadership Award, Outstanding Scholarship Award, 2009

Father John Morgan Scholarship, 2009 Benn Family Fund Youth Volunteer ScholarshipRELATED EXPERIENCE

Vanderbilt Sports Medicine, August 2009 – PresentClinical Intern

• Provide medical coverage for Vanderbilt University’s football team’s practices and competitions with a team of certified athletic trainers and physicians accumulating over 2,000 hours of experience

• Create and implement individualized rehabilitation programs to treat athletes’ specific injuries and conditions under the supervision of staff clinicians

• Observe and assist team physicians in their evaluation and treatment (including surgery) of injuries in order to broaden my understanding of sports medicine and the healthcare industry

• Administer therapeutic modalities including electric stimulation, ultrasound, iontophoresis, hydrotherapy, etc.

• Maintain medical records and ensure that required insurance, consent, and screening information is obtained

SCR Development Group, May 2011 – PresentDirector, Sports Science Applications

• Collaborate with a team of biomedical engineers and physicians to develop novel cryotherapy technologies for athletic muscular recovery

• Lead initial design efforts and prototyping of new configurations and improvements on current products

• Communicate with collaborative engineers and customers to improve the quality of our product• Awarded United States Patent for “Athletic Cooling and Heating Systems, Devices, and Methods”

COMMUNITY INVOLVEMENT

Volunteers of America (Kentucky), May 2008 – May 2009Founder and Director of Service Initiative

• Implemented a project involving over 100 volunteers that provided childcare and educational opportunities for impoverished children