2014
Project types: GH indicates Global Health | MT indicates MedTech
Graduate
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The Team
Student Team: Kevin Keenahan, Pratik Patel, Anant Subramaniam, Tiffany Tseng, Brock Webberman
Medtronic Team: Yong Cho, PhD, Wade Demmer, Subham Ghosh, PhD, Vanessa Pau
Clinical Advisors: Aravindan Kolandaivelu, MD, Department of Cardiology; Harikrishna Tandri, MD, Department of Cardiology; Calambur Narasimhan, MD, DM, Care Hospital, Hyderabad, India; Soumyadipta Acharya, MD, PhD, Department of Biomedical Engineering
Advisors: Dr. Vinod Sharma, PhD, Medtronic, Inc.; Naresh Pagidimarry, Glysure ?????
Abstract
Cardiac arrhythmia patients in the developing world can often go many years of experiencing symptoms such as dizziness and fainting, among others, without receiving proper care. Based on epidemiological data around 1.3 million cardiac arrhythmia patients should receive a pacemaker every year. Yet in 2009 only 20 thousand patients had access to this treatment and not much has changed since then. This team at Johns Hopkins is collaborating with Medtronic to identify and address the key bottlenecks for the appropriate diagnosis and treatment of cardiac arrhythmias in targeted Indian demographics. Early on the underserved segment was identified as a critically important population. These individuals have neither the access nor the capabilities to seek care for their arrhythmia ailments. Incorporating this population would not only lead to the downstream increase in pacemaker implantations but would also increase access to lifesaving interventions for millions of patients in dire need.
From ethnographic research in the field the team found the largest clinical opportunity was at the beginning of the care pathway with the Rural Healthcare Practitioners (RHCPs) who serve as the first line of care for roughly 65 percent of the Indian population. To ameliorate this systems-level problem, the team is developing a low-cost tablet device that improves the diagnostic capabilities of RHCPs for a variety of common medical conditions, including cardiac arrhythmias. The tablet leverages established clinical decision support system (CDSS) algorithms, but caters specifically to the disease states seen commonly by RHCPs to help them decide whether to keep a patient for treatment or refer them to a specialized doctor, such as a cardiologist. The system also includes an electrocardiogram (ECG) plug-in that allows RCHPs to perform ECGs within their clinic.
The team has formed a partnership with a local NGO in India, JSV Innovations, to implement field studies. A preliminary ECG monitor and CDSS system was brought to the field and received positive feedback from our partners in India and RHCPs alike. The team will be implementing a more developed prototype to further iterate on this concept and better understand the impact on a workflow and financial standpoint. By developing a system to empower the diagnostic abilities of lower levels of the healthcare system, we believe we can ultimately improve the diagnosis and treatment of cardiac arrhythmias in developing countries.
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The Team
Student Team: Eric Ashuckian, Jennifer Gilbertson, Julia Michalow, Matthew Petney
Clinical Advisors: Azadeh Farzin, MD, Department of Neonatology; Wilson Wang, MD, Jhpiego Indonesia; Elizabeth Cristofalo, MD, Department of Neonatology
Advisors: Kristy Peterson, Product Develop Manager, Jhpiego; Lindsay Litwin, Senior Program Coordinator, Jhpiego; Luke Mullany, PhD, Department of International Health, Bloomberg School of Public Health; Joanne Katz, ScD, MS, Department of International Health, Bloomberg School of Public Health; Pushkar Ingale, Laerdal Global Health, India; Jinjie Sunny Chen, Laerdal Global Health, Norway; Tor Inge Garvik, Laerdal Global Health, Norway
Abstract
Neonatal hypothermia affects an estimated 17 million newborns annually in developing countries. It is a significant contributing factor to the high rates of neonatal mortality that exists in this setting because hypothermia compromises neonates’ immune systems, thus increasing their susceptibility to other conditions such as infection and hypoglycemia. In Nepal neonatal hypothermia is the fourth leading cause of neonatal death and 16 percent of hypothermic neonates die during the first week after birth.
Despite high incidence rates for hypothermia, caretakers are frequently unaware of its occurrence because the early stages of hypothermia are asymptomatic. Our team has developed the IllumiNate hat to monitor neonatal temperature and alert care providers when newborns become hypothermic. The hat uses a low cost circuit that lasts for a minimum of three days, the highest risk period for hypothermia and its associated mortality. The alert is designed to be easily interpreted by non-literate mothers. Field studies in Nepal, Tanzania, and India have confirmed the need for hypothermia prevention and monitoring, and have guided the team’s design process. Bench-top testing has additionally demonstrated that the technology is comparable to the standard of care. The IllumiNate hat will be implemented with a training program on hypothermia prevention and management, and will empower mothers to monitor their babies for hypothermia, one of the most risky and easily corrected conditions that newborns face.
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The Team
Student Team: Melissa Diskin, Jan Lee, Pankti Shah, Barrett Yates
Clinical Advisor: Cherrie Evans, DrPH, CNM, Jhpiego
Advisors: Helge Fossan, Laerdal Global Health, Norway; Jinjie Sunny Chen, Laerdal Global Health; Harshad Sanghvi, MD, Jhpiego; Lynn Kanyuuru, MD, Jhpiego; Kristy Peterson, Jhpiego
Abstract
Each year, two million babies die annually from intrapartum-related deaths. Another one million are born with defects caused by birth asphyxia. To prevent complications the World Health Organization recommends that providers measure and record fetal heart rate every 30 minutes. The fetal heart rate provides critical information that determines if an intervention needs to be performed. Studies have shown that up to 43 percent of intrapartum neonatal deaths could be related to inadequate fetal heart rate monitoring. The current monitoring device, the Pinard horn, is inaccurate, time-consuming, fatiguing and difficult to use. When providers are unable to effectively monitor fetal heart rate during labor, it compromises the providers’ abilities to take action.
In partnership with Jhpiego and Laerdal Global Health, the design team has developed the Sikia monitor, an electronic fetal heart rate monitor that plays the fetal heart sound and displays heart rate. By using simple, inexpensive microphone technology, providers will have a faster, easier, and more accurate way to measure fetal heart rate. The team has recorded fetal heart sounds, improved signal quality, and has started developing an algorithm to calculate heart rate. The team has also received feedback by conducting interviews with midwives through Jhpiego, and through field visits to hospitals in India, Nepal, and Kenya. Additionally, the team has designed a study at a high-volume facility in Thika, Kenya to be performed this May. This study will provide additional users validation and feedback and quantify the value of the Sikia monitor over other devices. Overall, the Sikia monitor will increase the frequency of fetal heart rate measurement during labor, allowing for more timely interventions and thereby reducing the incidence of stillbirths and neonatal morbidity.
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The Team
Student team: Joshua Budman, Kevin Colbert, Aaron Enten, Michael Parlato, Ashley Polhemus
Advisors: Harshad Sanghvi, MD, Jhpiego; Soumyadipta Acharya, MD, PhD
Abstract
Anemia in Developing Countries
Anemia during pregnancy is defined as hemoglobin (Hb) concentration less than 10g/dL. Maternal anemia affects more than half of the pregnant women worldwide, causing 100,000 maternal deaths and 600,000 neonatal deaths each year. It also leads to poor outcomes for the child in the form of preterm birth, low birth weight, malnutrition, and stunted cognitive development. If it is identified early, cost effective therapies can combat the effects of anemia on the mother and the child. In fact, ferrous sulfate tablets have been shown to cure anemia if the patient is adherent. However, low adherence (<50 percent in many Asian and African countries) has been reported among pregnant women. In these populations, anemia is rarely caught early in pregnancy. If women are screened regularly, they can be informed of their anemic status and may be more likely to adhere to their recommended iron supplementation regimen.HemoGlobe: A Point of Care Hemoglobin Assessment Tool
HemoGlobe is a new paradigm in preventative medicine that will empower community health workers to take anemia screening to the doorstep of rural women. A low-cost, noninvasive sensor passes multiple monochromatic lights through the finger and onto a photo detector. Using principles of photoplethysmography, the device collects the transmitted light and processes the resulting waveform. The device then connects to a cell phone, allowing real time analysis of the waveform and classification of the patient as having severe, moderate, or mild anemia. Preliminary results are based on waveforms that were collected from approximately 500 patients in Nepal and eastern India. These waveforms were subjected to a variety of nonlinear regression techniques, neural networks, and a support vector machine to develop the calibration curve.After the waveform is collected patient data can be documented on the cell phone and, along with their anemia assessment, sent to a central server via SMS, MMS, phone call, or email. Uploading this data either to a server or the cloud creates a real-time database of anemia prevalence and distribution. This database can be used to track progress in areas with a disproportionate burden of maternal anemia, as well as facilitate resource allocation decisions by public health organizations. Use of this device on an international scale has the potential to reduce rates of maternal mortality, prevent premature births, and increase the health of young children in developing countries by facilitating point of care medical assessment and education for mothers with limited access to healthcare.
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The Team
Student team: Aaron Enten, Julia Michalow, Ashley Polhemus, Brock Webberman
Clinical Advisors: Michael Boland, MD, PhD, Department of Ophthalmology; William Anderson, MD, PhD, Department of Neurosurgery; Deborah Stein, MD, MPH, Shock Trauma Center at University of Maryland Medical Center; Wendy Ziai, MD, Department of Neurology; Betsy Zink, MS, RN, CCNS, CCRN, CNRN, Neuroscience Critical Care Unit
Abstract
Headaches in the Emergency Department
Each year, six million patients visit emergency departments (ED) in the United States (US) with headache as their primary complaint. While many of these patients are seeking treatment for intolerable, recurrent headaches such as migraines, up to 15percent of patients suffer from serious neurological conditions with emergent underlying pathologies. These high risk conditions are not easily discernable from benign headaches and can be fatal, requiring urgent diagnosis and treatment. However, neurological crises are misdiagnosed as migraines in up to 25percent of cases, resulting in wrongful discharge from the hospital, worse outcomes, and a higher chance of mortality.
Elevated intracranial pressure (ICP) is not only a symptom of many of these conditions, but also an independent point of concern, and treatment to reduce ICP is vital for preventing permanent brain damage. Some of the first observable symptoms of raised ICP occur in the eye. However, high intra and inter-observer variability during ophthalmic examinations have been reported of physicians in the emergency room and this prevents these tests from being used at the point of care.
InSpect: A Physician’s Aid for Timely Diagnosis
The inSpect system takes the skill of the ophthalmologist and places it in the hands of the emergency care provider. The inSpect digital ophthalmoscope collects video of the eye and uses processing software to automatically measure several key ophthalmic parameters on the pupil and the back of the eye. These parameters include abnormal pupillary response to light, papilledema, venous engorgement, and spontaneous venous pulsations. Our software leverages masking techniques used to detect and isolate the vasculature, with blob detection algorithms used to measure and track both the pupil and the optic disk. Videos are stabilized mechanically with a disposable eyepiece, as well as using digital rendering and point feature mapping. Our current eyepiece prototypes have been shown to reduce video instability due to hand movements during examinations by up to 90 percent.
Videos are analyzed to provide a real-time assessment of intracranial pressure, which is indicative of neurological crisis. Care providers can thus integrate this ophthalmic assessment with the physical examination for more accurate and timely differentiation between high and low risk headaches. Patients will benefit from faster administration of therapy and more reliable therapeutic decision-making to achieve optimal outcomes.
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The Team
Student team: Matthew Petney, Eric Ashuckian, Jan Lee, Pankti Shah, Tiffany Tseng
Clinical Advisors: Roy Brower, MD, Department of Pulmonary and Critical Care Medicine; Brendan Canning, PhD, Department of Allergy and Clinical Immunology; Geetika Sood, MD, Department of Infectious Diseases; Julianne Perretta, MSEd, RRT-NPS, CHSE, Johns Hopkins Simulation Center; Katie Mattare, RT, Department of Adult Respiratory Care
Abstract
Annually, approximately 800,000 patients rely on mechanical ventilation (MV) delivered through a breathing tube to survive. Over time the presence of a breathing tube prevents the elimination of bacteria that build up in the lungs. Within a matter of days patients on ventilation often develop complications and secondary infections that worsen their condition. For instance, ventilator-associated pneumonia (VAP) increases a patient’s hospital stay by two weeks and is directly responsible for 36,000 deaths each year. Based on historic Medicare data, only 83 percent of ICU costs are compensated. ICU cases with complications and infections significantly lengthen a patient’s stay, causing the hospital to lose money. Each day in the ICU costs the hospital $3,200. When a patient develops a secondary infection such as VAP hospitals are not reimbursed for the additional resources used and lose on average $12,000 per patient.
Coughing is one of the body’s main defenses against respiratory infection. The breathing tube prevents ventilated patients from coughing effectively because it prevents the closure of the glottis, which in turn does not allow sufficient pressure to build up in the lungs. Our device, the PreVent, is a ventilator attachment that restores a patient’s ability to effectively cough and integrates seamlessly into the intensive care unit (ICU) workflow.
Preliminary data has shown that briefly obstructing the airway during an exhalation, as the PreVent does, creates an effective cough profile. The team has also performed safety testing at the Johns Hopkins Simulation Center to ensure that the PreVent does not interfere with a patient’s ventilation therapy. Over the next few months the team will perform bench testing to demonstrate efficacy in moving mucus. In addition, an IRB study has been submitted to gather flow and pressure characteristics directly from mechanically ventilated patients to develop the cough detection system.
The PreVent will help hospitals save thousands of dollars in patient care and excel in quality metrics. Most importantly, by allowing patients to safely eliminate mucus from their lungs the PreVent will improve the respiratory function of critical care patients, prevent secondary infections, and expedite recovery.
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The Team
Student team: Kevin Colbert, Jennifer Gilbertson, Michael Parlato, Pratik Patel, Barrett Yates
Clinical Advisors: Ashish Nimgaonkar, MD, MS, MSc, Department of Gastroenterology; Pankaj Pasricha, MD, Department of Gastroenterology, Bayview Medical Center; Thomas Donner, MD, Department of Endocrinology; Lawrence Cheskin, MD, Weight Management Center, Bloomberg School of Public Health; Hien Nguyen, MD, Department of Surgery, Bayview Medical Center
Abstract
Type 2 Diabetes: A Shift in Thinking?
Twenty five million Americans live with type 2 diabetes mellitus (T2DM) in the United States. Traditionally, T2DM has been treated with insulin therapy and oral hypoglycemics which compound over a patient’s lifetime, cause weight gain, and lead to greater insulin resistance. Bariatric surgery has been shown as an extremely promising treatment for T2DM as recognized by the American Diabetic Association. However, very few patients qualify for surgical treatment and are willing to accept the risks inherent to the invasive procedure. Research over the past several decades has pointed to exclusion of the proximal gut from contact with nutrient flow as the cause of diabetic remission.
The Stasys Approach
After conducting an extensive literature search and speaking with leading bariatric surgeons, endocrinologists, and gastroenterologists, the Stasys team has identified a novel device-based approach to mimic the metabolic effects of surgery while minimizing risks. Exclusion of the intestine from alimentary flow is achieved via an intestinal lining delivered by orally ingested capsules. The mechanism of our first-generation devices has been validated using a bench-top peristalsis model. Furthermore, several proof of concept in-vivo rat studies have validated the impact of our approach on blood glucose levels. Stasys is on track for large animal experiments to validate the safety and efficacy of our device. Patients, providers, and payers have expressed support of the Stasys treatment due to the early demonstration of efficacy, low risk profile, and cost of the device. The Stasys approach has the potential to improve the lives of millions of type 2 diabetics in the United States and beyond.
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The Team
Student team: Joshua Budman, Melissa Diskin, Kevin Keenahan, Anant Subramaniam
Clinical Advisors: Leigh Ann Price, MD, Department of Plastics and Reconstructive Surgery; Susan Rhee, MD, Wound Healing Center, Bayview Medical Center; Gabriel Brat, MD, MPH, Department of Surgery; Alex Kor, DPM, Department of Orthopaedic Surgery; Lew Schon, MD, Department of Orthopedic Surgery, Union Memorial Hospital
Abstract
Wound care is not glamorous but a $20 billion global market is hard to ignore. Most of us could not imagine living with an open sore, but 8 million Americans do. Chronic wounds, defined as those that do not heal for more than six weeks, are on the rise due to the increase in patients with comorbidities such as diabetes, obesity and old age. These wounds are often composed of dead and infected tissue which must be removed in order for the wound to heal. Debridement, or removal of the dead tissue, is performed by a specially trained clinician who cuts out the dead tissue with a scalpel. Wound healing progress is measured through both area reduction and change in tissue composition from dead and infected tissue to ingrowth of new healthy tissue. Wound area measurement and tissue composition, both crucial metrics to determining the success of wound treatment, are currently performed visually, implying a highly subjective process that can have errors of up to 40 percent. Patients require debridement procedures at a high frequency, making chronic wound care an expensive and labor-intensive process. With the cost of treatment continuing to skyrocket the wound care market needs a solution which will reduce costs by increasing healing rates and deskilling wound care, allowing more patients to continue treatments at home instead of in a specialized care setting.
Tissue Analytics proposes to change the way wound care is conducted. The WoundMEND System consists of three proprietary components: WoundSTIM, a microneedle injection with an FDA-approved enzymatic debriding agent; WoundCAP, a bristle-coated dressing for continuous debridement; and WoundTRACK, an app that tracks wound healing. The system is designed to be used at home and can be implemented by a home-care nurse instead of a clinician. With a simple photo taken by the user wound healing can now be monitored at home on the WoundTRACK App, which can measure many parameters that cannot be determined with visual inspection. To dress the wound WoundSTIM is used to deliver the enzymatic debriding agent within large areas of necrotic tissue, breaking it down faster than the standard of care. Rat studies in over 60 necrotic wounds show that WoundSTIM application causes a 20 percent increase in blood flow to the wound, an important indicator of healing. The WoundCAP dressing acts as a real-time and continuous care provider removing necrosis and biofilm as it develops.
Tissue Analytics is pursuing a staged developmental strategy focusing initially on building and commercializing the WoundTRACK App. On building credibility and ensuring a consistent revenue stream we will introduce both the WoundSTIM and WoundCAP technologies to move wound monitoring and healing to the patient’s home. In this way, the WoundMEND System can autonomously care for wounds with a substantial increase in frequency of wound monitoring and unprecedented instantaneous intervention. Use of the WoundMEND System is projected to increase healing rates by 25 percent and save payers 50 percent over the cost of care for a single wound.
Undergraduate
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The Team
Student Team: Sandya Subramanian, Melinda Chen, Taylor Lam, Powei Kang, Chun Ming So, Akash Premkumar, Caitlin Romanczyk, Quinn Salditch
Sponsor and Clinical Advisor: Todd Cohen M.D., Cardiac Inventions
Abstract
Our device is a wearable cardioverter defibrillator (WCD) is designed to address the shortcomings of the standard of care, the Zoll LifeVest ®. There are four main factors that lead to a high noncompliance rate with the LifeVest: comfort, frequency of alarms, inability to sleep and image. Our device is designed with a “slip-on and forget” concept in mind to minimize necessary user maintenance and interaction with the device. It is in the form of a shirt as opposed to a harness, which maximizes comfort and improves image. The weight from the defibrillation components is better distributed for a more balanced center of gravity, making the garment feel lighter. With our design, the center of gravity moves 10.9 cm closer to the center of gravity of the patient. Our integrated design requires minimal assembly on the user’s part. A small, separate user interface that is worn like a watch is used to wirelessly communicate with the garment. The user interface consists of visual feedback via LCD display and LED’s, auditory feedback via alarms, and tactile feedback via vibrational motors to alert the user of an impending shock. Our current prototype includes an ECG detection circuit with a rudimentary heart rate calculation algorithm wirelessly coupled to the watch interface. With our design, user comfort is highly increased, the maintenance process is simplified, and the general aesthetic is improved.
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The Team
Student team: Kutay Muslu, Allie Berges, Miguel Dorante, Rohit Gummi, David Israel, David Wu, Miguel Sobral
Clinical Advisor: Roberto Sosa, MD, All Children’s Hospital
Abstract
In an effort to reduce the incidence of treatment related complications in newborns with Respiratory Distress Syndrome and increase ease of use, we have designed a device to administer continuous negative extrathoracic pressure to newborns with Respiratory Distress Syndrome weighing over 1000g. Our design allows for easy placement over the anterior region of an infant’s chest. By utilizing negative pressure, the device will take advantage of reductions in incidences of treatment related complications shown in literature. The device continuously provides a negative pressure of up to 15cm H2O, in 1cm increments, over the targeted area. The negative pressure is transmitted to the lungs and will increase the infant’s residual capacity, allowing the neonate to breathe naturally. To maximize ease of operation while maintaining efficacy of treatment, the device was designed with three parts: a semi-rigid body, a seal, and a strap. A semi-rigid dome over the thoracic area provides for a cavity capable of holding the necessary negative pressure. The seal seeks to minimize pressure leaks. Finally, a semi-rigid strap will hold the device in place and minimize downward force of the device on the sensitive skin of the infant. We are in the process of testing the device on newborn porcine sample.
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The Team
Student team: Sydney Rooney, Katie Hochberg, Logan Howard, Austin Jordan, Divya Kernik, Jeff Knox, Allie Sanzi, Ernest Scalabrin
Clinical Advisors: Nicole Chandler, M.D., All Children’s Hospital; Paul Danielson, MD, All Children’s Hospital
Abstract
Prehospital blood loss to injured soldiers with junctional hemorrhage (JH) en route to hospital care is a major cause of death. The reason is adequate control of JH is not currently available. To address this need, we are designing, developing, and testing a device that controls high-pressure junctional hemorrhage in cavity-shaped wounds in combat scenarios. To improve upon the current standard, our device aims to reduce the quantity of blood lost during the first hour of a high-pressure hemorrhage (60-80 mmHg) to less than 50 percent of the total blood volume, or around 2.5 L. Once activated by a soldier via a twisting mechanism, our device combines a polyol and a diisocyanate in a mixing chamber, allowing the chemicals to react and form rapidly expanding polyurethane foam that fills the wound and applies pressure to the walls of the cavity. The foam is able to adapt to complex wounds, or irregular wound tracts where the origin of the hemorrhage is unidentifiable, allowing for more effective targeting and treatment of the bleed. Our device is the size of a foam marker, facilitating easy portability. Additionally, it can withstand military conditions as it consists of a durable HDPE canister and chemicals that are stable at temperatures up to 100 ºF for up to 2 years. Application to the civilian population is being considered.
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The Team
Student Team: Nathan Buchbinder, Nayan Agarwal, Lindsay Bauer, Miguel Dias, Kush Gupta, Patawan Jareonvongrayab, Renu Kondragunta, Vignesh Ramchandran
Clinical Advisor: Clifford Weiss, MD, Department of Radiology; Luis Diaz, MD, Department of Radiation Oncology
Abstract
Existing brush biopsy technology for the collection of biliary tract cells collects a large enough sample (5000 cells) only 40 percent of the time, resulting in inconclusive pathology reports for the diagnosis of cancer and other GI diseases. To meet this clinical need, a modified brush has been designed that collects a larger quantity of cells. The device consists of a flexible drive shaft 1.5m in length and with a bend radius of between 2 and 4cm, allowing for rotational control of the brush. The brush head is helical in shape, with a length of 1.5cm and helix radius of 0.75mm, resulting in a pitch of 32.5 degrees with 5 rotations and a hollow core 1mm in radius that provides a space for cell collection. Surface coating with electropositive biopolymers similar to poly-L-lysine and chitin were found to significantly improve cell adhesion by as much as 350 percent compared to existing nylon coatings. Bristles of various hook and loop designs were designed, and are in the process of being prototyped and tested.
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The Team
Student Team: Steven Dalvin, Qasim Mahmood, Rachel Lee, Steven Albers, Haley Huang, Graeme Steller, Shriya Awasthi, Annie Hou
Clinical Advisor: Lonny Yarmus, DO, Department of Pulmonary and Critical Care Medicine
Abstract
To help pulmonologists achieve better diagnostic results from transbronchial lung biopsies, we have designed OPZItrieve – a device that is able to pass through the working channel of a therapeutic bronchoscope and collect tissue samples. When used in conjunction with an existing foreign body retrieval tool known as a cryoprobe, OPZItrieve will be capable of retrieving tissue samples (~5mm in diameter) that are nearly 200 percent larger than those obtained with the current standard. By applying a 40 percent compression to tissue samples retrieved via cryoprobe, OPZItrieve is able to successfully remove samples that were previously too large to fit through the working channel of a bronchoscope, allowing pulmonologists to retain visual acuity of the target region and monitor for bleeding as is done with the current standard. Testing is ongoing to demonstrate the efficacy of the OPZltrieve.
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Student team: Aaron Chang, Amanda Valledor, Allison Moyer, Dominic Thomas, Jin Chung, Paola Donis, Rajiv Deshpande, Erik Tan
Clinical Advisor: Aitana Juan, MSc, Doctors without Borders
Abstract
To streamline the workflow and increase adoption of controlled temperature chain (CTC) processes by NGO’s and country MOH’s, we have designed and developed a cost effective vaccine time indicator (VTI) which indicates vaccine stress due to days spent outside the cold chain. The CTC considers each vaccine’s particular heat-stability and allows for transport and storage of vaccines outside the cold chain for a defined period of time and temperatures immediately before administration. While CTC can alleviate the impact of cold chain infrastructure problems and save 50 percent of the logistics costs of the current last mile vaccine system in developing countries, there are still issues with the current CTC delivery method. Our solution replaces the manual tallying system used to keep track of days in the current CTC protocol with an automated time indicator based on color-changing ink. The color change is accurate to within +/- 6 hours by the end of 4 days, making it optimized for the first CTC approved vaccine for meningitis A, MenAfrivac®. The per vial form factor and color scheme of our indicator integrates consistently with the current vaccine vial monitor that is found on all UNICEF vaccines to enhance usability and facilitate adoption. Lastly, our device extends the potential reach of CTC beyond single antigen mass campaigns to the traditional, multi-antigen day to day operation of community health workers. With the estimated 5-6 additional vaccines which will receive CTC approval with varying time requirements in the next 2 years, our device will facilitate the scalability and growing acceptance of CTC as the new standard of care in last mile vaccine delivery.
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The Team
Student team: Pujan Desai, Erin Rhoads, Wes Bernier, Jerry Wang, Sakina Girnary, Stephanie Herrera, Candice Gard, Richard Shi
Clinical Advisor: Edith Gurewitsch, MD, Department of Gynecology & Obstetrics
Abstract
To improve workflow in OB/GYN surgeries we have designed a mechanical locking arm that allows doctors to achieve secure retraction in vaginal surgeries and avoid using assistants holding hand-held retractors. The base of the arm clamps to the hospital bed and a standard hand-held retractor is fixed to the other end. The arm consists of several locking joints that can be released to adjust the retractor-arm’s position by squeezing a handle near the retractor-fixed end and re-secured by releasing this handle. This mechanism allows for quick adjustments based on the visual and tactile feedback of the clinician to meet the momentary needs of the procedure. When locked, the device securely maintains a force sufficient for retraction (~30-40 N) to allow the clinician to visualize the intended area. This retraction method provides an adequate view of the operating site (> 5 cm diameter circle) and ensures minimal intrusions of this space for periods up to 1 hr. Further, the device is versatile and can be applied in a wide range of procedures requiring vaginal access. Our solution can potentially provide retraction assistance that is more convenient for the doctor, reduces crowding of the OR space, reduces the number of personnel required, and improves overall clinical efficiency in OB/GYN.
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The Team
Student team: Simon Ammanuel, Wesley Chan, Gabriel Chew, Matthew Kercher, RishiKesh Mohan, Zaid Ashai, Emily Borst, and Jon Hochstein
Clinical Advisor: Paul Danielson, MD and Nicole Chandler, MD, Department of Pediatric Surgery; All Children’s Hospital
Abstract
To reduce the occurrence of dislodgment of endotracheal tubes during single lung ventilation procedures in pediatric surgery, we have designed, prototyped and tested a new mechanical endotracheal tube cuff design combined with a biomaterial component. This novel design experiences greater friction with the bronchus and trachea than current devices, thereby increasing the amount of force required for tube dislodgement to occur. The new tube has most of the same features as the current standard of care but also includes an enhanced cuff. The cuff incorporates texturing that allows for better traction with the inner lining of the airways. In addition, the cuff is coated with a cellulose-based adhesive component that does not stick to the trachea but still makes removal the tube more difficult. To quantify how effectively our endotracheal tube design combats dislodgement, we used in vitro testing of excised piglet tracheas. We observed a 200 percent increase in the force required to dislodge our novel cuff design relative to the force required to dislodge cuffs that are considered the current standard of care. Future in vivo piglet testing will provide further data on dislodgement force in living specimens.
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The Team
Student team: Anvesh Annadanam, Ravi Gaddipati, Luis Herrera, Brad Isaacs, Eric Xie, Clay Andrews, Adarsha Malla, Erica Schwarz
Clinical Advisor: Chetan Bettegowda, MD, PhD, Department of Neurosurgery; Sheng-fu Larry Lo, MD, Department of Neurosurgery
Abstract
To enable spine surgeons to more accurately place pedicle screws and reduce associated breaches in spinal fusion procedures, we have designed and prototyped AccuSpine, an improved pedicle probe to replace the current “ball-and-stick” model probe. AccuSpine is able to provide feedback to the surgeon regarding where it is located within the pedicle and alert the surgeon of an impending cortical wall breach with both vibrational and visual feedback. The device consists of a spherical handle incorporating three 100 pound resistive force transducers to measure forces in three different axes. When the surgeon pushes the probe from soft to hard bone, a sudden force spike will occur, signifying a breach. The handle also houses a feedback system obtained using a small button vibrational motor as well as four red LED lights that flash, respectively, when a breach is detected. AccuSpine’s feature set enables projected reductions in operating time by 15 percent with projected cost savings of 10 percent per surgery, an average of $9,000 per procedure.
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Student Team: Alexia Haralambous, Richard Chen, Phani Gaddipati, Shohini Ghosh, Bryan Kuo, Pin-Hsuan Lee, Alex Mullen, Corbin Rosset
Clinical Advisors: Samuel Yang, MD, Department of Emergency Medicine; Edbert Hsu, MD, MPH, Department of Emergency Medicine
Abstract
To improve medical decision-making in the emergency department (ED) of hospitals, we have developed a novel respiratory rate (RR) measurement device for use in ED triage. The current standard of care for respiratory rate (RR) measurement in ED triage is manual measurement, often for 15 or 30 seconds. Due to this, and nurses under appreciation of RR, nurses rarely measure RR accurately, if at all. Although a broad range of RR measurement technology exists, few devices are both cost-effective and suited for the transient nature of triage. Our device is designed to measure RR in 15 seconds or less, with an accuracy of ±2 breaths per minute (bpm) of the World Health Organization’s (WHO) gold standard. It consists of a sensor to be clipped on the patient’s clothing over the abdomen or taped to the skin on the patient’s stomach. A data acquisition system records motion of the sensor due to breathing, and translates that to a RR frequency for nurse to record. Incorporating this technology into the triage workflow does not increase the average time it currently takes to measure vitals, 160 seconds. The device is designed to causes little to no discomfort to the patient, so as not to interfere with the patient’s true RR.
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The Team
Student Team: Megan Lamberti, Marisa Babb, Jonathan Hunt, Michael Ketcha, Ashwyn Sharma, Saranga Arora, Kathleen Kusworo
Clinical Advisor: Kusum Thapa, MD, Jhpiego
Abstract
Every year 300,000 maternal and 3 million neonatal deaths are caused by complications during and surrounding the time of childbirth; 97 percent of these occur in the developing world and many of these deaths could be prevented with improvements in clinical care. Of the 14 “essential” parameters tracked during labor, uterine contraction frequency and duration take the longest to measure, up to 10 minutes per hour per patient. Most often midwives do not do this as part of the standard of care and it prevents them from recording contraction frequency and duration at all. Due to the need to record frequency and duration, we have designed a simple, low-cost uterine contraction monitor for use in the developing world. The device is similar in shape to the tocodynamometer which includes a probe that protrudes into the surface of the patient’s abdomen. Upon contraction the probe deforms a sensor which detects the stiffening of the uterus during a contraction. Output is a reading displayed on the contraction monitor. We are currently developing the technology to send a text message to the midwife to indicating the contraction rate.
