Vanderbilt University

Department of Biomedical Engineering

Senior Design Project

NCIIA Grant Proposal for a Pacemaker Detection Protocolfor MR Suites

6 December 2012

“The Coil Kids”

Zach Eagleton

Josh Shannon

Michael Shannon

Josh Stewart

Sam 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 otherimplantations. 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 Cardiology43.7 (2004): 1315-324.

ZACHARY EAGLETON

Current Address 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 Shannon

Current Address: Permanent Address:

Vanderbilt University, PMB 343924 (352)410-1741 5092 Mentmore Ave.

Nashville, TN 37235 Spring Hill, FL 34606

EducationVanderbilt University, Nashville, TN

Major: Bachelor of Engineering in Biomedical Engineering May 2013

Current 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 Eaters

Research - 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 Shannon

Current Address: Permanent Address:

Vanderbilt University, PMB 355011 (352)410-1641 5092 Mentmore Ave.

Nashville, TN 37235 Spring Hill, FL 34606

EducationVanderbilt University, Nashville, TN

Major: Bachelor of Engineering in Biomedical Engineering May 2013

Current 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 Society

Research - 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 Stewart

Home Address: School Address: 9 Revolutionary Road c: 978-844-4038 411 Village at Vanderbilt

Acton, MA 01720 Nashville, TN 37212

Education

Vanderbilt University, Nashville, TN

Bachelor of Engineering, Biomedical Engineering

Minor: Mathematics

GPA: 3.0

Spring 2013

Colby College, Waterville, Maine

2009-2010

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 WorkExperience

Sung Laboratory, Vanderbilt University

Research 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, MA

Intern (Summer 2011)

  • Helped design a modern “Jackson” spinal table for surgery

Volunteer Experience