Project types: GH indicates Global Health | MT indicates MedTech
Student Team: Erin Reisfeld, Shruthi Rajan, Dhananjay Sethi, Madeleine Clegg
Clinical Advisors: C. Sridevi, MBBS, DNB, Lalukota Krishna Mohan, MBBS, MRCP, Satadal Saha, MBBS, MS, FRCS, Clifford Weiss, MD, Harikrishna Tandri, MBBS, MD, Naresh Pagidimarry, MS, Peter Johnson, MD, Stuart Russell, MD, Daniel Nyhan, MBBCH, MD, Viachaslau Barodka, MD
Sponsor: Medtronic Team —Val Eisele, Adam Hines, Kesavan Potti, Idara Uko, Yong Cho
Team Brady is working in collaboration with the Medtronic Foundation to assess and address the barriers to pacing therapies in India. After multiple field studies, the team has observed ineffective management of bradycardic patients in emergency situations. Proper care is stifled by the inaccessibility of temporary pacing, which is a bridging therapy to a permanent pacemaker. In particular, in low-resource settings where imaging technologies and infrastructure do not exist, patients either die before reaching a cardiologist or reach a cardiologist in a life-threatening state.
To address the lack of availability to temporary pacing, Team Brady is developing an assistive device to allow doctors in settings without imaging to safely and confidently temporarily pace a patient. The assistive device is a hybrid needle system that ensures safe venous access by mitigating the potential risks of a blind procedure. The main components of the device are a mechanical needle-syringe system that allows for larger needle integration without compromising the placement on the patient’s neck and a double-aspiration method that allows the physician to confirm access into the jugular vein twice during the procedure. These components as a system were designed to ensure patient safety, encourage physician confidence, and standardize venous access protocols.
Student Team: Wes Bernier, Trent Langston, Nichaluk Leartprapun, Qian Liu and Jackie Wanjala
Clinical Advisors: David Kass, MD, Peter Johnston, MD, Chao-Wei Hwang, MD PhD, Viachaslau Barodka, MD, Majd AlGhatrif, MD, Stuart Russell, MD, Soumyadipta Acharya, MD, PhD, Youseph Yazdi, MBA, PhD, Lawrence Aronhime, MBA, Matt Oberdier, PhD, Aditya Polsani, MS, Michael Parlato, MSE, Clifford Weiss, MD
Sponsor: Boston Scientific Team — Umang Anand, PhD, Andrew Bicek, PhD, Paul Chouinard
Heart failure affects the lives of 5.1 million Americans and cost the U.S. economy $39.2 Billion in 2010. An important aspect of managing HF is proper intravascular fluid optimization. The parameter that best quantifies fluid status is Left-Ventricular End-Diastolic Pressure. However, the current standards of care in obtaining fluid status assessment involve either a catheterization procedure that is accurate but inaccessible for regular use or inaccurate, nonspecific and subjective physical examinations. This inadequate assessment of a patient’s fluid status can lead to suboptimal medical dosing and, subsequently, increased incidences of rehospitalization. In recognition of this significant clinical need, CardiON is developing a safer, cheaper and more accurate way of monitoring LVEDP.
CardiON’s scientific insight comes from the observation of the interplay between various cardiovascular pressure, acoustic, and electrical waveforms. Using multiple noninvasive hemodynamic measurements, our system employs a patient-specific algorithm to derive LVEDP in real time. So far, the team has developed and validated its approach using retrospective human data and pig experiments. CardiON has been able to demonstrate high correlations of LVEDP values (R-square > 0.9, p < 0.001) with the new noninvasive approach as compared to the invasive gold standard. Furthermore, preliminary analysis demonstrated no clinically significant differences between the actual and predicted LVEDP values (Prediction S.E. <3mmHg). CardiON’s LVEDP values fall well within the precision and accuracy thresholds that clinicians desire. Johns Hopkins clinicians and CardiON’s Boston Scientific collaborators have expressed great excitement and anticipation in this new LVEDP monitor.
Moving forward, CardiON hopes to finalize the design of the prototype and continue validation of the patient specific algorithms in a way that informs possible future generalization. CardiON has obtained provisional patents on its designs and algorithms and hopes to begin pursuing regulatory approval (De Novo, Class II) in the near future. By enabling quantitative assessment of fluid status in all settings, CardiON hopes to revolutionize the way patients all over the world live with heart failure.
Student Team: Kimber Ashman, Brian Ma, Krairat Mairin, Mihika Reddy, Dhananjay Sethi
Clinical Advisors: Youseph Yazdi, PhD, Paul Segal, DO, Chris Jeffers, PhD, Steve Brooks, MD, Francisco Tejada, PhD
Proper hydration is a problem that is central to everyone’s health. Both overhydration and underhydration have detrimental medical consequences for various demographics. In the U.S. alone, more than half a million people will be hospitalized each year for preventable dehydration. Chronic patients, military personnel, and the elderly in particular need to be vigilant in monitoring their fluid intake. Fluid overload within our target patient population costs the health care system $7.6 billion per year. For military personnel, just a 4 percent decrease in hydration levels is enough to significantly degrade their physical and mental performance. However, there are currently no products on the market that continuously track hydration status.
MarsMedical is developing DrinkSync: a wearable, telemedicine-linked solution for monitoring hydration status. We output this result to the user, and our software will also track performance on your phone or computer, to help you build better habits over time. Users can take this information to see how their hydration levels change throughout the day. We can help you determine whether you’re under, over, or adequately hydrated and fuel your body accordingly. For chronic patients, the device will track the user’s actions and wirelessly communicate that information to central software, which will help doctors tailor treatments to the patient’s habits. With proper hydration, you can improve your cardiovascular function, exercise performance, cognitive function, and even mood.
Student Team: Wes Bernier, Allie Sibole, Melody Tan, and Jackie Wanjala
Clinical Advisors: Azadeh Farzin, MD, Kusum Thapa, MD, Neena Khadka, MD, Lindsay Litwin, and Kristy Peterson
In overcrowded neonatal care units where each caregiver is responsible for many babies, there is a serious risk of neonatal distress going unnoticed. Traditional newborn vital sign monitors can alert providers to subtle indications of illness but are too expensive for hospitals in low-resource settings and ineffective in understaffed facilities. We observed this problem firsthand in Nepal and Indonesia and identified a need for caregivers in neonatal units to be able to tell when babies are experiencing vital sign abnormalities in order to know when they are in need of immediate intervention.
As a team of master’s students at the Johns Hopkins Center for Bioengineering Innovation & Design, we are in the process of developing a newborn vital signs monitor for low-resource settings. Our system has three components:
We believe that this system will enable earlier detection of neonatal distress, leading to earlier, more effective interventions and alleviating the burden on overworked caregivers.
Student Team: Aaron Chang, Allie Sibole, Madeleine Clegg, Patience Osei and Sriram Chadalavada
Clinical Advisors: Nevin M. Katz, MD, Viachaslau Barodka, MD, Derek M. Fine, MD, Dan E. Berkowitz, MBBCH, J. Trent Magruder, MD, Sharon Allan, RN, Steve Brooks, MD, Rengaswamy Srinivasan, PhD, Soumyadipta Acharya, MD, PhD, Youseph Yazdi, PhD
Acute kidney injury, defined as a sudden loss of renal function, occurs in 15 percent of the 600,000 cardiac procedures in the U.S. each year, leading to costly and morbid ICU stays. One of the most common causes is a drop in renal perfusion, leaving the kidney deprived of oxygen and unable to filter properly. As a result, the kidney decreases its urine production and increases its sodium retention. Kidney damage is potentially reversible through simple interventions, but the current gold standard detects the injury 48 hours too late. This has significant clinical and economic impact. Up to 2 percent of patients undergoing cardiac surgery leave the hospital requiring dialysis, and hospital-acquired acute kidney injury costs the U.S. health care system $10 billion each year.
The Renalert team is working with cardiac surgery, anesthesiology, and nephrology specialists at Johns Hopkins Hospital to facilitate the early detection of acute kidney injury. Our device, Renalert, provides real-time feedback about kidney function during cardiac surgery and in the intensive care unit. It uses continuous urinalysis to provide a patient-specific indication of kidney perfusion, and incorporates a unique algorithm of perioperative risk factors and hemodynamic parameters to assess the patient’s risk of acute kidney injury. Renalert detects declines in kidney function at the onset, alerting clinicians to make timely interventions that can prevent the associated complications of acute kidney injury.
Student Team: Brian Ma, Qian (Linda) Liu, David Blumenstyk, Krairat (March) Mairin, Trent Langston, and Sriram Chadalavada
Clinical Advisors: Satadal Saha, MD, MBBS, MS FRCS, Soumyadipta Acharya, PhD, Satya Brata Acharya, MD, Aditya Polsani, MS, Michael Parlato, MSE
Access to health care is a basic human right. Yet in India, more than 700 million rural people have limited access to deficient care with 360 million of them having no access to any form of health care at all, including primary care. Although the government has built a system of free public clinics and hospitals, about 40 percent of them are under-performing. In the absence of quality care facilities, Rural Medical Practitioner with empirically acquired experience and no knowledge base have emerged as a predominant form of care provider for the rural community. While they do provide immediate access to health care, their lack of knowledge and training leads to frequent misdiagnoses, overmedication and sometimes catastrophic outcomes.
Our Rural Health Kiosk model is an alternative service delivery model that offers primary care through an innovative ecosystem for just $1 per visit. We equip trained Health Assistants with our History-taking and Diagnostic Intelligence system, which guides them with initial history-taking in a manner that mirrors a doctor’s thought processes and transmits these results to a remotely located doctor. Armed with this information, the doctor can consult the patient, conduct further physical examination through the HA, and prescribe a treatment plan as if he or she were there in person.
Operating under a lean startup model, we have started two kiosks in West Bengal, seeing paying patients every day. With the maturation of the HDI, our model will grow, becoming a network comprising hundreds of kiosks to serve millions currently without access to qualified care.
Student Team: Kimber Ashman, Aaron Chang, Ian Graham, Nichaluk Leartprapun, Patience Osei, Mihika Reddy
Clinical Advisors: Barrett Yates, MSE, Sunny Chen, Tor Inge Garvik, MSc, Cherrie Evans, CNM, MSN, DrPH, Kusum Thapa, MD, FRCOG, MPH, Blami Dao, MD, Annie Clark, CNM, MPH, Harshad Sanghvi, MD
Many caesarean sections are preventable. During our August field immersion trips in Nepal and India, we witnessed high rates of caesarean sections and low rates of instrumental deliveries. In low- and middle-income countries, caesarean sections not only increase costs, but also maternal and fetal morbidities. From the discussions we have had with OBGYNs and midwives in India and Nepal, along with members in the public health sector, we have recognized that a key contributor to the high prevalence of caesarean sections is the lack of training in managing the progression of the second stage of labor and performing assisted deliveries. Many midwives and skilled birth attendants do not have the confidence to perform proper fetal head assessments during vaginal exams, which is critical to the decision-making process for appropriate referral for assisted delivery. Currently, there are no low-cost labor management training simulators for LMICs that adequately teach fetal head assessment.
Our team is creating a low-cost simulation tool that provides a method of safely practicing the vaginal examination skills that are essential to clinical decision making during the second stage of labor. Our device will help teach proper assessment of fetal head position, station, orientation, and moulding during a vaginal exam. We hope to enable midwives and SBAs to feel more confident in managing labor by allowing them to practice the skills that are vital to appropriate decision making and thereby prevent unnecessary caesarean sections.
Student Team: David Blumenstyk, Ian Graham, Shruthi Rajan, Erin Reisfeld, Melody Tan
Clinical Advisors: Zoltan Mari, MD, Reza Shadmehr, PhD, Yousef Salimpour, PhD, Robert Atkinson, JD, Gad Alon, PT, PhD, Neil Rothman, PhD, Youseph Yazdi, PhD, MBA, Soumyadipta Acharya, MD, PhD, Paul Fearis, Lawrence Aronhime, MBA, Aditya Polsani, MS, Pratik Patel, MSE, William Anderson, MD, PhD, Kristen Bowsher
Tremtex is working in conjunction with clinical and research partners at the Johns Hopkins School of Medicine to develop an intervention to help Parkinson’s disease patients manage their debilitating motor symptoms. Parkinson’s disease is an incurable, neurodegenerative disorder that affects more than 1 million people in the United States and 7 million people worldwide. The standard of care for Parkinson’s disease is medication; however, the effectiveness of medication wanes as the disease progresses. Another option for patients in advanced stages of the disease is deep brain stimulation, an expensive and invasive surgical procedure with strict eligibility criteria. This leaves a significant number of patients without an effective intervention.
Tremtex is addressing this gap by providing a low-risk solution for patients whose symptoms are undermanaged with existing interventions. The team has designed STIMband, a noninvasive electrical stimulation device, which delivers low and safe doses of transcranial direct current stimulation, to the motor cortices of the brain. The result is the reduction of motor symptoms, including tremors, and improved mobility. STIMband has been designed to ensure patient safety and usability, allowing patients to receive treatment within the comfort of their homes.
Student Team: Alex Diehl, Melissa Austin, Johnny Beal, Wesley Chan, Thomas Du, Schuyler Metzger, Aine O’Sullivan, Peter Yao
Clinical Advisor: Michelle Zwernemann
We have generated two prototypes that work together to improve the usability and accessibility of the pin-locking suspension system for lower-limb prostheses. We aim to address the needs of a patient population with limited hand dexterity and related issues such as vision impairment. Accordingly, the designs were created with a focus on ease of use, durability, and full compatibility with pin-lock systems currently used in the market. Our system consists of a device called PinAlign that mitigates the problem of pin misalignment, as well as a lever-like release mechanism called ReleaseAssist that eases pin disengagement and doffing. The mechanism of the PinAlign has been built to withstand forces well above those present in normal gait without the pin detaching. Specifically, we aim to achieve a force failure point during swing phase at least as high as existing pin lock systems, which fail at close to 580 N of force. To test the mechanical performance of our designs, we will conduct static tests to measure the failure point of the PinAlign under suspension and load-bearing forces experienced during gait. ReleaseAssist will be tested by evaluating its ability to push in the release button with the leg under different loads. Finally, to rate the performance of our design in the criterion of ease of use, the system incorporating both components will be evaluated through timed donning/doffing, measurements of the number of unsuccessful donning attempts, and a user questionnaire issued to amputee participants.
Student Team: Michael Clark, Arianne Papa, Angelica Herrera, Michael Mow, Seung Jung, Annabeth Rodriguez, Jose Solis, Prateek Gowda
Clinical Advisors: Luis Garza, MD, PhD, Sewon Kang, MD
Recent advancements in stem cell therapies have shown the potential to revolutionize the treatment of many conditions. However, there is still a need to consistently and accurately deliver stem cells to target regions in the solid organs of the body—particularly the skin. Skin stem cell therapies currently under investigation have the potential to reverse hair loss, heal wounds, and alter the phenotype of the epidermis. We have designed a device that allows physicians to deliver stem cells to target dermal regions at adjustable volumes with minimal risk of contamination or damage to the cells.
Student Team: Yu Xu, Kevin Z. Xin, Kaiyuan Wang, Jacob Schick, Alexander de la Vega
Clinical Advisors: Alexander H. Hoon, MD, MPH, Tara Johnson, MD, Elaine Stashinko, PhD, Brittany DeCroes, PT, DPT, Robert Allen, PhD
Scissoring is one of the major challenges affecting ambulation in individuals with cerebral palsy. There are few effective methods currently available to diminish scissoring. With this in mind, we developed a device with the capability to diminish scissoring gait. The orthosis utilizes a physical barrier (specially fabricated blocks) to separate the legs. The blocks are strapped onto each thigh and are connected by a metallic bolt so that the two blocks can easily slide along each other during the gait cycle. Our prototype is constructed of Acrylonitrile butadiene styrene using a 3-D printer (Dimension 1200es). The contact surface of the block is covered with Teflon to reduce friction. The inner surface, which touches the thigh, is covered with soft sponge rubber to improve patient comfort; the straps are made of nylon.
Thickness of the ABS slabs can be adjusted to accommodate patients of different body sizes. In addition, the color of the outside cover can be changed. This enables the device to match in color with the patient’s clothing, thus making the device less conspicuous.
This orthosis has been tested in a clinical setting with results demonstrating that use of the device increased patient gait speed by 200 percent and mitigated scissoring of the legs. The increased gait speed could be attributed to increased stability. The orthosis has a total mass of 1.50 kilograms and hence long term use of the device will not induce patient fatigue. We plan continued development of the orthosis, and then to obtain IRB and FDA approval prior to clinical trials.
Student Team: Lucas Shores, Jessica Lin, Steph Cabralr, Tatiana Rypinski, Willis Wang, Albert Lee, Aseem Jain, Tony Wang
Clinical Advisors: Alexander T. Hillel, MD, David J. Feller-Kopman, MD
To reduce complications with current endotracheal stents, we have designed, prototyped, and tested the Hole-Punch Stent. This silicone-based stent incorporates a nitinol wire to maintain patency of the airway, an open channel to reduce mucostasis and restenosis, and strategically placed holes to reduce stent migration. The stent can be rolled up to allow for easy deployment with flexible bronchoscopy. The stent is modular, in that the design can be adapted to different sizes and the final product will accommodate patients with tracheal diameters between 14 millimeters and 25 millimeters. The stent that we tested had an inner diameter of 18 millimeters and an outer diameter of 22 millimeters in order to model stents used for an average to large trachea. The mechanical properties of the stent were tested against industry standards. Pressure tests were also conducted in an ex vivo porcine tracheal model to optimize the stent for in vivo testing. Future large animal testing will reveal the effectiveness of our biologically focused mechanical design in reducing complications for patients with endotracheal stenosis who rely on airway stent technology to breathe.
Student Team: Haley Huang, Tom Catullo, Stephen Johannesson, Barbara Kim, Esteban Urias, Eric Chiang, Anshul Subramanya, Tony Sun
Clinical Advisor: Allan Belzberg, MD
Every year, there are more than one million spinal surgeries in the United States targeting nerve problems that occur mainly in senior patients. 32 percent require a revision surgery due to a degeneration of the initial condition. Of these 320,000 surgeries, 18 percent result in a serious clinical complication called a cerebrospinal fluid leak, which is any sort of tear or puncture in the thin membrane, known as the dura mater, that surrounds the spinal cord. Each of these 57,600 incidences extends patient hospitalization by 3-5 days, incurs an average cost of $6,500 per patient, increasing the financial burden on the U.S. health care system by around $375 million annually. There is currently no device on the market that deals specifically with the separation of scar tissue, bone, and dura in the spinal area. Instead, doctors use a variety of instruments called periosteal elevators, which generally have a spatula-shaped end designed to scrape tissue from the bone. However, these are general surgical tools that are not designed to tear tissue gently and can easily damage the dura if the surgeon creates too much sheer force or makes contact with the dura due to lack of visibility. To address these issues, we have designed a tool that employs ultrasonic vibrations concentrated on a thin, flattened tip in order to separate the scar tissue from bone. The tip design features an L-shaped curvature that conforms to the geometry of the spine, sharp edges on either side of the tip that enable it to cut laterally through scar tissue, a dull tip that offers protection for the spinal cord membrane underneath, and a means of cooling through water ejected from an irrigation hole located on the distal end of the tip. We have demonstrated that our device will reduce the force applied during scar/ bone separation by 45 percent and will perform force testing and dural characterization experiments in rabbit spines in the coming year.
Student Team: Austin Jordan, Tiffany Chen, Amy Kang, Marc Madore, Lisa Ni, Sarah Sukardi, Siavash Parkhideh, Nisu Patel
Clinical Advisor: Edith Gurewitsch, MD
To facilitate effective screening for preterm birth, we have designed an instrument to measure the diameter of the cervix. The instrument is scissor like in form and has a rotary sensor at the hinge using the sensor and the instrument’s inherent geometry, the distance between the two ends of the device can be precisely measured. The design allows for easy bilateral compression of the cervix in order to obtain the resting and minimum diameter of the cervix, the ratio of which has been shown to be indicative of cervical stiffness and preterm birth. The device is made out medical-grade austenitic steel, the standard for similar clinical instruments. The device accommodates a wide range of vaginal canal and cervical diameters. Tests planned include mechanical testing of the prototype (to test strength), accuracy testing, and precision testing (with several model cervixes with known shore hardness).
Student Team: Ivan Kuznetsov, Kristina Li, Calvin Zhao, Conan Chen, Tomas Gaigalas, Sunny Thodupunuri, Evan Smith, James Chen
Clinical Advisors: All Children’s Hospital, Paul Danielson, MD, Nicole Chandler, MD
Herniation is the main complication of laparoscopic surgery procedures. It occurs when the fascia layer that protects the muscles and internal organs is not properly closed, and sometimes not even closed at all, after laparoscopic surgery. To reduce time spent in the operating room, post-operative pain for the patient, and cost incurred for additional procedures as a result of herniations, we designed and prototyped VeraClose—a fascial closure device that provides an automated closure method for port sites ranging from 5 millimeters to 30 millimeters that can deliver multiple consistent sutures. VeraClose is designed to be faster than manual suturing, which is currently the standard of care. It is a cylindrical 10 millimeters device with a removable handle. The handle is made out of stainless steel and meant to be reuseable. The body of the device houses one needle with a novel geometry that minimizes the pinching of the fascia and delivers a consistent bite. To be able to close multiple ports, the device has multiple cartridges of suture attached to caps that serve to pass suture back and forth to create a loop that closes the port. These caps have a novel geometry that allows it to be reloaded and deloaded as the needle closes the fascia. Currently, a scaled-up prototype of the device has been 3-D printed. We are looking to print VeraClose in true scale, which will allow us to do robustness testing in PDMS and operations testing in cadavers.
Student Team: George Chen, Ashish Aman, Stephen Chen, Kathryn Hahn, Arda Ozilgen, Dylan Hirsch, Vignesh Sadras, Yamini Vyas
Clinical Advisors: Dr. Soumyadipta Acharya, Dr. Satadal Saha, Dr. Sunip Banerjee
Cardiovascular disease annually accounts for 30 percent of all global mortality, and this rate is expected to increase over the next few decades. In India, 17.2 percent of the total mortality rate is attributed to ischemic heart disease, a subset of CVD. The availability of CVD diagnostics is limited in low-income countries, particularly in rural areas. The high cost for these diagnostics, coupled with geographic location and lack of proximity to experienced doctors, limits their use and the subsequent treatment regime that patients can receive. To solve these problems, we have created PranaPulse, a low-cost 12-lead electrocardiogram device for diagnosing IHD in rural patients. The device connects to an Android device through a mobile application, which helps to collect and wirelessly send ECG data over to a cardiologist in an urban center. The cardiologist can then prescribe an individualized treatment for each patient electronically. To simplify electrode placement, we have also designed harness systems that are used to place the electrodes firmly and anatomically accurately on the patient. We propose to test each of these components with consideration that the device must be able to withstand harsh conditions, able to be reused, and simple to use.
Student Team: Sai Vangala, Nick Clyde, Alex Monroe, Carly Loveland, Kelsey Bower, Felix Yu, Ashutosh Jindal, Mariah Schrum
Clinical Advisors: Carine Stromquist, MD, Benjamin Torres, MD, Richard Williams, RRT
To help reduce the incidence of retinopathy of prematurity, bronchopulmonary dysplasia, and other complications related to hyperoxia/hypoxia in premature infants, we have designed a system which will automatically monitor the blood oxygen saturation (SpO2) levels of the infants and will adjust the fraction of inspired oxygen (FiO2) when necessary in order to keep the saturation levels within a specified range. The current standard of care involves nurses monitoring several infants and manually adjusting FiO2 levels as needed. Our system will improve upon this standard by monitoring a single infant in real time, allowing it to react with more speed and precision. The final design will minimize the amount of time spent by the infant outside of the SpO2 target range when on oxygen therapy, thereby reducing the risk of ROP and the number of alarms in the clinical environment. It will also free up more time for the nurses to attend to the infants in other ways. The system will first be tested in a neonatal simulation center under various simulated conditions. It must be able to react to a wide range of trends in the given SpO2 values, including both gradual and rapid fluctuations, and it must react to these trends in ways similar to how the nurses react. If the system can be shown to be effective, it will be tested in a neonatal intensive care unit against the current standard of care.
Student Team: Malvi Hemani, Kunal Patel, Jason Park, Huilei Wang, Melissa Lin, Yunchan Chen, Wooyang Son, Nolan Benner
Clinical Advisors: Dr. Acharya, Dr. Allen, Patricia Gomez, CNM
Midwives in developing nations monitor 71 million births annually. However, despite the presence of a midwife, roughly 800 women die each day from pregnancy complications that are avoidable through proper monitoring of labor progression. Currently, the write out recommends midwives in rural clinics monitor the progression of labor using a partograph, which is a tool that tracks 14 labor parameters. Uterine contraction data is one of the most important partograph parameters, but is monitored incorrectly 88 percent of the time due to the lengthy and difficult process of monitoring by hand. The lack of proper contraction monitoring leads to undetected complications, including prolonged or obstructed labor and severe bleeding. To address this clinical need, we have developed TocoTrack, which is a uterine contraction monitor designed for developing countries. Through automation of the process, TocoTrack will enable more midwives to properly track the progression of labor and make accurate diagnoses, having a widespread impact on maternal and newborn health.
Student Team: Rodolfo Finocchi, Xindi Ai, Christopher Corbett, Angelo Cruz, Rachel Yung, Rohith Bhethanabotla, Rohit Joshi, Manyu Sharma
Clinical Advisor: Soumyadipta Acharya, MD, MSE, PhD
To better assess pulmonary function and inform patients with respiratory diseases and their providers of the necessity of treatment, we designed and prototyped a fluidic oscillation spirometer. The device inputs a patient’s exhaled air and outputs a unique air pattern that is sensed by two microphones and processed in a mobile device application. Our current prototype contains an obstacle inside that traps inputted exhaled air and creates two vortices that, due to changes in the pressure inside the device, cause airflow to switch rapidly between the device’s channels. Microphones, which pick up the out-of-phase pattern, are placed at the bottom of the device and powered by a battery. The audio signal is then processed to remove ambient noise and develop a flow vs. volume and a volume vs. time graph typical of spirometers. These graphs are then sent through telemedicine to pulmonologists in a remote location, who can examine the results and determine key pulmonary values such as FEV1 (Forced Expiratory Volume after 1 second), FEV6, and FVC (Forced Vital Capacity). With all its parts, the device falls under $25, requires minimal calibration, and has no moving parts, making it a low-cost, easy-to-use solution that approaches clinical standards. Tests planned include mechanical testing of the prototype to examine durability under varied conditions (drop testing, temperature/humidity testing, mucus testing), flow testing to determine linear correlation between frequency and flow, and accuracy testing to meet standards of spirometry set by the American Thoracic Society. In addition, improvements to the design are planned, such as designing a more sustainable method of powering the device (e.g. with solar power) and developing a real-time graph output for our mobile application.
Student Team: Renu Kondragunta, Kalyna Apkarian, Nathan Buchbinder, Sarah Daggett, Amanda Facklam, Chang Hwan Choi, Victoria Fang, Dani Kiyasseh
Clinical Advisor: Lew Schon, MD
Common surgical interventions for tendon dysfunction in the foot and ankle involve reconstructions in which a healthy tendon is harvested to reinforce or replace a damaged one. In these surgeries, clinicians must spend valuable time navigating to and attempting to cut the tendon of interest with tools like scissors or scalpels, which damage surrounding blood vessels, nerves, and even the tendon itself. To reduce operating room time and minimize damage to tendons and peripheral structures during tendon reconstruction surgeries of the foot and ankle, we have designed and prototyped a tendon harvesting device. TenoSlice is designed to fit snugly around the tendon to allow for rapid navigation to the location of desired cutting and minimal disturbance of surrounding structures. Its controllable cutting mechanism also ensures the safety of the tendon itself until the surgeon is ready to cut it. TenoSlice consists of a reusable handle and shaft component, as well as a disposable cutting component that is inserted fully into the handle and shaft when cutting is desired. The tendon and cutting component are kept entirely separate until the end of the shaft in order to prevent premature damage to the tendon. We anticipate producing more robust prototypes, which will allow us to continue with usability testing in cadavers. Additional tests planned include side-by-side usage comparisons with the existing standard of care in order to compare time needed to harvest the tendon, as well as human factors testing.
Student Team: Taylor Lam, Chloe Quinlan, Nick Bello, Christopher Coughlan, Miguel Sobral, Jessica Wu, Tommy Athey, Victor Dadfar
Clinical Advisor: Ricky Lu, MD, MPH
To decrease the number of incorrectly inserted and removed subdermal in-arm contraceptive implants in developing countries, we have generated a training tool that aims to effectively teach lower-level health care providers to successfully insert and remove the contraceptive implants. The Contraceptive Implant Training Tool Kit has improved on three main aspects of training: biofidelity of the tissue layers of the arm model, human factors emphasis, and removal training. Biofidelity was improved in two ways. First, the standards of care lack a fat layer that accurately simulates the fat layer of the arm; this is a problem because inserting the implant into the fat layer is the biggest reason implants are ineffective once inserted into the body. Having silicone layers to model muscle, fat, and skin (instead of cotton, latex, etc as used by the SOC) will allow the health care provider a training experience much closer to that of a real patient. Second, we have made the training tool wearable so that in addition to being used as a stand-alone trainer, like the SOC, it can also be worn by another student who is pretending to be a patient which is standard training protocol. The ability to wear the trainer allows for more biofidelic training because actual biomarkers, such as the elbow, can be used to train providers on proper implant placement. Wearability also emphasizes human factors in the training and prepares students for patients that move, as many do during the procedures. Finally, all other SOC lack any removal-specific training, which is widely accepted to be the more difficult of the two procedures associated with this form of contraception, whereas the CITT Kit contains a portion of the trainer that will train students in the difficulties of the removal procedure.