Project types: GH indicates Global Health | MT indicates MedTech
Student Team: Demetri Monovoukas, Matthew Nojoomi, Shravya Srigiri, Scott Stanley
Clinical Advisors: Krishnamohan Lalukota, MBBS, MRCP, Arpan Chaudhuri, MBBS, MD, Abhijeet Shelke, MBBS, MD, DNB, Ronald Berger, MD, PhD, Harikrishna Tandri, MBBS, MD, Youseph Yazdi, PhD, MBA, Soumyadipta Acharya, MBBS, PhD, Aditya Polsani, MS, Naresh Pagidimarry, MS
Sponsor: Medtronic Team — Wade Demmer, Yong Cho, Erin Reisfeld, Pankti Shah, Thomas Lulic
The 2015-2016 CBID-Medtronic team represents the third year of a global health collaboration initiative between Johns Hopkins and Medtronic. The overall goal of the project is to identify and address the most significant barriers preventing pacemaker adoption in India, particularly in the more underdeveloped regions. After multiple visits to the field, the team identified that secondary-care facilities in India lack adequate treatment capabilities for emergent bradycardic patients. The standard of care for these emergency patients involves the implantation of a temporary pacemaker until they are effectively stabilized or receive a permanent pacemaker. However, because secondary-care facilities in India typically do not have catheterization labs, implanting cardiologists, or other necessary resources, they are unable to perform temporary pacemaker procedures. Due to the relevance of temporary pacing in the overall patient care pathway, the team has chosen to focus on increasing access to temporary pacing at the secondary-care level in order to increase the overall number of patients who go on to receive permanent pacemakers.
The team’s proposed solution is a pacemaker lead navigation simulator, to help increase the confidence and competency of blind lead navigation at secondary care facilities. The simulator consists of an anatomically accurate model of the heart vasculature that provides electrical signal feedback as an indication of lead position in order to educate and familiarize physicians with the lead navigation procedure. As the user advances a lead through the simulator, the electrogram (EGM) signal corresponding to the location of the lead tip is displayed on a monitor that represents the ECG machine used during the actual procedure. The lead navigation simulator not only allows for less experienced physicians, such as emergency and critical care doctors, to gain experience performing lead navigation, but it also encourages the practice of ECG-guided navigation, a reliable and proven technique used in the US. The simulator directly addresses the lead navigation barrier by increasing physician confidence and helping achieve proper lead placement, which ultimately minimizes associated complications.
Student Team: Sakina Girnary, Ramji Rengarajan, Kavya Singampalli, Victor Yu, Stacie Zwolski
Clinical Advisors: Umang Anand, PhD, Jon Resar, MD, Kenton Zehr, MD, Kaushik Mandal, MBBS, MD, Rani Hasan, MD, Peter Johnston, MD, Sammy Zakaria, MD, MPH, Steven Brooks, MD, MBA, Aditya Polsani, MS, Youseph Yazdi, MBA, PhD, Soumyadipta Acharya, MD, MSE, PhD
An estimated 1.6 million people in the United States have moderate to severe tricuspid regurgitation (TR), a condition in which the tricuspid valve leaflets do not coapt, creating an orifice that allows blood to flow backwards from the right ventricle into the right atrium. If left untreated, this condition can cause edema, liver congestion, shortness of breath, and right heart failure, among other complications that significantly reduce patient quality of life. The one-year survival rate for severe TR patients is a mere 64%. Despite the severe implications of TR, the disease is largely under-treated in the medical community since the current treatment carries too high of a risk. The standard of care is an open-heart surgery in which an annuloplasty ring is secured around the valve annulus to reduce dilation, allowing the leaflets to coapt. Operational mortality rates for this procedure range from 8-12% for a patient’s first open heart procedure and 10-25% for a reoperation. The alternative to surgery is medical management with diuretics, which does little to improve patient quality of life. Of the 340,000 patients diagnosed with moderate-severe TR annually, only 10,000 receive the surgical treatment that they need. Our team is developing a low-risk percutaneous (catheter-based) treatment system in order to address the large underserved patient population with severe functional TR. There has been substantial development in such percutaneous intervention technologies in the structural heart space over the past 15 years. In the tricuspid space, companies have recently begun developing percutaneous solutions that either replicate sub-optimal surgical techniques or have yet to prove long-term efficacy. The surgical technique that our solution is replicating percutaneously, ring annuloplasty, has been proven surgically to significantly reduce the degree of tricuspid regurgitation, provide the highest freedom from recurrence of TR, and has the highest durability compared to other approaches. We are currently working through the iterative loop of designing, manufacturing, and testing in ex vivo pig hearts with the goal of soon being ready for in vivo implantation of our device in animals. We will continue to iterate based on the results. All aspects of our design will be continually validated by our team of physicians in order to ensure that we are developing a solution that will be safe, efficacious, and has the potential to become widely adopted.
Student Team: Chanya Elakkad, Joseph Pia, Victor Yu and Sam Zschack
Clinical Advisors: Soumyadipta Acharya, Youseph Yazdi, Alain Labrique, Azadeh Farzin
Over 66% of newborn deaths happen during the first week of life due to the fragile immune system of the neonates that results in the rapid development of fatal conditions. In lower income countries, the majority of the population receives their primary health care by trained community health care workers (CHWs). The majority of births in the developing world occur at home, so the CHWs are critical to providing clinical assessments and referrals to healthcare facilities. Despite proven success of this intervention, the limited number of trained CHWs and frequency of visits creates a bottleneck for care. Because of this, the timing of proper assessment aligning with the onset of symptoms is happenstance. One caregiver that is not limited in their ability to monitor the neonate is the mother. We identified theunmet need to design interventions to improve maternal recognition of neonatal illness at home and prompt care seeking behavior.
A task shifting of neonatal assessment and recognition of danger signs to mothers is a promising strategy to improve early identification of neonatal illness. To accomplish this our team has developed INFORM (INfant monitoring FOR Mothers), a system that provides reliable and consistent monitoring of infants for identification of danger signs of severe illness during the critical first week of life to facilitate early referral of sick neonates. INFORM consists of two parts – an Interactive Voice Response (IVR) based mHealth platform and a low cost reusable wearable device. CHWs can enroll mothers into this system and provide them with the wearable device close. Once the mother or a family member notifies the system that she has given birth through a simple SMS or call, INFORM’s mHealth platform places a voice call to the mother or family of a newborn infant every day during the critical first seven days of life, starting a “virtual CHW visit”. The system will walk a mother through a clinical assessment of her baby and the wearable device will provide accurate measurements of the critical vital signs, temperature and breathing rate. Using this system, mothers will finally be empowered to identify severe neonatal illness effectively and in a timely manner.
Student Team: Amal Afroz Alam, Emily Eggert, Neha Goel, Elizabeth Lebling, Sean Mattson
Clinical Advisors: Soumyadipta Acharya, MD, MSE, PhD, Nick Durr, PhD, Paul Nagy, PhD, FSIIM, Junaid Razzak, MBBS, PhD, James Bon Tempo, MS, Khanjan Mehta, MS
Many developing countries face challenges providing primary healthcare to their populations, resulting in increased disease burden, mortality, and healthcare-related poverty. Rural populations feel this lack of access most, as they are far from the major cities where health resources are concentrated. In India, for example, over 70% of the population lives in rural areas, but 60% of healthcare infrastructure is located in urban centers. There are as few as one doctor per thousand patients, and low-skill, unlicensed practitioners often serve the needs of the rest of the population.
Telemedicine, or medical care that is delivered or supported by telecommunication, has developed as a common technique for addressing the care access and quality gap. Because it allows for a doctor to provide consultation remotely, telemedicine is a natural solution for bringing care to a last mile setting. However, gaps still exist between the healthcare needs of remote communities and the type of care that telemedicine platforms can support. These gaps include lack of low-bandwidth capabilities, reliance on highly-trained healthcare providers, and platforms that are highly-tailored for specific tasks or use cases.
InteleCare (Figure 1) aims to address these shortcomings by using a knowledge-engineered expert system to task shift healthcare activities from skilled physicians to minimally-trained healthcare workers. Using the Knowledge Enabled Clinical Information (KECI) software platform, InteleCare can support Community Health Workers (CHW) to take a comprehensive patient history and conduct a quality physical exam. It is built on top of OpenMRS, a robust patient data management system, so physicians can view patient data, make clinical recommendations.
The InteleCare system can support private sector health systems, global development organizations, NGOs, and governments to improve their telemedicine capabilities, bringing higher quality care to more people.
Student Team: Kelly Lacob, Sean Mattson, Matthew Nojoomi, Maddie Wilson, Alison Wong, MD, and Sam Zschack
Clinical Advisors: Justin Sacks, MD, MBA, Clifford Weiss, MD, Bill Padula, PhD, Andrew Malinow, MD, Amanda Owens, CWOCN, Bill Lansinger, Youseph Yazdi, PhD, MBA, Soumyadipta Acharya, MD, PhD
Pressure ulcers are injuries to the skin and underlying tissue, usually over a bony prominence such as the sacrum, ischial tuberosities, heels, or back of the head. They occur as a result of prolonged pressure compounded by secondary factors such as shear and moisture, and can begin to form in as little as two hours—a window smaller than the length of many common surgeries or the frequency with which healthcare providers are able to regularly check on their bedbound patients. The extent of damage from prolonged pressure does not become apparent until days later, making it difficult to know where or when was the precipitating event and how to act to prevent it. Existing risk scores miss 60% of patients who go on to develop pressure ulcers and current preventative methods have a high financial and time cost, limiting widespread implementation for all patients.
Despite being classified as Never Events by the Agency for Healthcare Research and Quality in 2008, meaning they are avoidable and therefore unacceptable, 3-6% of all patients still develop pressure ulcers while in hospital, leading to more than 1.8 million new cases in the U.S. every year. Not only are hospitals not reimbursed for the cost of treating these wounds, with an average cost of $37,000, but hospitals in the lowest performing quartile also receive cuts in overall federal reimbursements. Altogether, pressure ulcers cost the U.S. health system over 11 billion dollars annually, equivalent to 44% of total wound care spending.
Our solution, the Mercury Patch, is comprised of two main components: a wireless pressure-sensing adhesive patch, and a software user interface. The adhesive patch is approximately 4 inches in diameter and provides force-offloading, shear protection, and moisture control while collecting pressure data via a smart-sensing layer. The patch can communicate wirelessly to any device, displaying current pressure, pressure over time, how much the patient has been moving and when he or she was last repositioned. The system can also integrate with the patient’s electronic medical record, streamlining documentation.
From the data provided, doctors and nurses will have objective data on a patient’s pressure ulcer risk and be able to provide targeted interventions and care plans. By checking the pressure readings via the device, they can also be assured that patient repositioning has been effective. Since the Mercury Patch is low-cost and integrates into existing workflow, it can be used preventatively for all patients. Not only will this improve the quality of patient care and save hospitals money, but by providing a record of movement it will help ensure that patients are getting the necessary activity toavoid other serious complications. The Mercury Patch is the only option on the market that empowers healthcare providers to provide their patients with proactive, informed, and personalized pressure ulcer prevention and care.
Student Team: Kendall Covington, Sakina Girnary, Teja Maruvada, Ramji Rengarajan, Kavya Singampalli
Clinical Advisors: Soumyadipta Acharya, MD, PhD; Rashmi Asif, MBBS; Cherrie Evans, CNM; Tor Inge Garvik, MS; Jennifer Gilbertson, MSE; Lindsay Litwin, MPH; Pushkar Ingale, MDes; Swati Mahajan, MBBS, MPH; Harshad Sanghvi, MD; Pallavi Sinha, MBBS; Rachel Willardson, MS
Each year, 350,000 women and 2 million babies die from birth-related complications. In India specifically, the UN Millennium Development Goals 4 and 5 aim to reduce high infant mortality rates, decrease the maternal mortality ratio, and increase birth attendance by skilled health professionals. To achieve this, nursing schools that are currently training students using a standardized curriculum have recently added Skills Labs to expose students to skill-based and simulation-based training practice, apart from a clinical internship during the final year of nursing education. However, many of the labour monitoring skills taught in the curriculum are not translated to the clinical site due to the lack of interactive, immersive and integrated training. This leads to a lack of nurse empowerment to make important decisions in emergent situations that can save both the mother and child.
We have developed a training system to improve the current labour monitoring training system by integrating the measurement, recording, interpreting and acting aspects, habituating nursing students to make more timely measurements and decisions, and encouraging a low-dose high-frequency training approach without the need for direct faculty involvement. Our device, Physim, allows students to practice and learn measurements, plot data onto a partograph, and make decisions throughout the progress of labour. It incorporates a physical model containing modules for fetal heart rate, contractions, and cervical dilatation, which connects to a flipbook user interface where the user plots data on a partograph. After each measurement is complete, the student assesses the parameters to ensure that labour is progressing normally and appropriate actions are taken.
PhySim offers significant advantages over the traditional case study approaches by encouraging dialogue and discussion among the students and enhancing the learning for both the user and the operator. PhySim also incorporates group-based simulation, that has been shown extensively to improve learning comprehension and retention.This system habituates the student to take measurements in a timely manner, make decisions at each time point after measurements are taken, and contextualize those measurements in the progression of labour. By providing exposure to both the normal and abnormal progression of labour in the training setting using a low dose high frequency training routine, students will be able to build their confidence before reaching the clinical site, and will be better-equipped to make evidence-based decisions in practice.
Student Team: Amal Afroz Alam, Emily Eggert, Elizabeth Lebling, Demetri Monovoukas, Scott Stanley
Clinical Advisors: Youseph Yazdi, PhD, MBA, Andrew Lane, MD, Chris Jeffers, PhD, JD, Bob Storey, Cathy Becker, Ary Chernomorsky
Chronic rhinosinusitis (CRS), recurrent and persistent inflammation of the nasal sinuses, is a chronic condition that affects almost one in eight Americans, yet few options exist for reliable treatment of the disease’s debilitating symptoms. Patients with CRS find it difficult to lead a normal life while faced with headaches, insomnia, painful facial pressure, and persistent infections. While almost every CRS sufferer uses sinus rinses daily, this regimen is ineffective for patients with the most advanced forms of the disease. As a result, sufferers must try increasingly expensive and invasive treatments, ultimately sending over half a million people to undergo functional endoscopic sinus surgery (FESS) every year. However, the procedure only marginally increases the efficacy of saline rinses and will have to be revised in a third of patients within three to six years. Overall, this process is costly for both the individual and the healthcare system, as patients spend thousands of dollars on over the counter treatments, incur $8.6 billion in direct surgical costs, and cause $24 billion in lost economic output annually. In an effort to help patients who have received FESS better rinse their sinuses, competitors have developed treatments such as balloon sinuplasty and nasal stents that attempt to open sinus ostia and maintain sinus patency. However, none of these options ensure reliable sinus access or facilitate direct sinus irrigation. Salient ENT addresses these shortcomings with the Hana Catheter (Figure 1), a product designed to bring saline and other therapeutic fluids directly to inflamed sinus tissues. The Hana Catheter system includes a novel, low profile nasal device and an external rinse bottle that interfaces with the internal catheter. By providing a conduit through constricted sinus openings, the Hana Catheter can increase fluid delivery up to eight-fold over the standard of care. This solution provides a more targeted treatment delivery option for CRS patients, which can minimize recurrent symptoms and reduce the need for surgical revision procedures.
Student Team: Kelly Lacob, Maddie Wilson, Alison Wong, MD, and Stacie Zwolski
Clinical Advisors: Tigistu Adamu, MD, Lindsay Litwin, MSPH, Rachel Willardson, MS, Robert Malkin, MS, PhD, Ed Hutton, James Cobey, MD, Barclay Stewart, MD, Youseph Yazdi, PhD, MBA, Soumyadipta Acharya, PhD, MD
For the first time in history more people are dying from a lack of access to safe, essential surgical care than from communicable diseases. The Lancet Commission’s Global Surgery 2030 report and the World Bank report on the importance of surgery in developing countries recently placed this issue at the forefront of the global health agenda. One of the greatest but most underserved barriers to safe surgery is the availability of functional biomedical equipment; it is estimated that 50-70% of all biomedical equipment in developing countries is partially or completely nonfunctional, resulting in approximately a 10% referral or cancellation rate for surgeries.
Tech Connect is a mobile application that provides technicians with the resources they need to ensure that functional surgical equipment is available where and when it is needed most, effectively increasing patient access to safe surgery. There are five main features to Tech Connect: 1) digitized troubleshooting flowcharts that break down the most common problems and associated repairs into manageable steps; 2) skill tutorials for commonly needed mechanical, electrical, and plumbing skills; 3) resource libraries that include generic guides from respected institutions such as the World Health Organization and Engineering World Health as well as references to equipment-specific manuals from manufacturers; 4) a Call an Expert function that connects techs in real-time to product or thematic area experts who can assist them through repairs; and 5) convenient capability to notify hospitals and central medical stores of the need to order spare parts, directly through Tech Connect. Tech Connect also collects data and generates a report every time it is used, providing highly useful information to hospitals, Ministries of Health, and medical device companies that can be used for policy, procurement, and training decisions, among other uses. Our design is backed by ethnographic research as well as data that proves giving technicians access to generalizable skills and informational and human resources can allow them to repair up to 70% of equipment malfunctions.
We have demonstrated proof-of-concept by trialing our MVP with 40 potential end-users in Ethiopia.The response was extremely enthusiastic, suggesting we are moving in the right direction. We also received valuable feedback that will be implemented in future development. Once Tech Connect is finalized, we plan to generate revenue through annual subscriptions to the application, which provides end-users with access to the support services and Ministries of Health, hospitals, and medical device companies with access to the analyzed data. The primary distribution channels will be through university and vocational training institutions, but we can also reach techs already in the field through in-service training workshops.
Student Team: Kendall Covington, Chanya Godzich Elakkad, Teja Maruvada, Joseph Pia, Shravya Srigiri
Clinical Advisors: Edward James (Jamie) Wright, MD; Nikolai Sopko, MD, PhD; Caroline Garrett, DA Soumyadipta Acharya, MD, PhD; Youseph Yazdi, MBA, PhD; Aditya Polsani, MS
A urethral stricture is a fibrotic narrowing of the urethra, which acts like a tough scar tissue and leads to voiding complications. With symptoms including frequent and painful urination, penile inflammation, increased risk of urinary tract infection, and even renal failure if not treated early enough, its ramifications have serious impacts on the quality of life for affected men across the globe.
Existing options for patients fall into two buckets: effective invasive open surgery (urethroplasty), and minimally invasive procedures (dilation, urethrotomy, or self -catheterization) with subpar outcomes. Patients typically begin with a minimally invasive treatment such as dilation or urethrotomy, (~160,000 performed annually in the U.S. alone). These often end up with a recurrence, as rates of recurrence average at 70%, and are as high as 91% for a repeat procedure. Although the gold standard treatment, urethroplasty, is suggested if they experience a recurrence, many undergo repeat ineffective treatments to avoid open surgery. This cycle not only aggravates the patient’s condition but is also economically inefficient to the health care system.
uCure is developing TAURUS, a minimally invasive tool for the treatment of urethral strictures. It allows transurethral delivery and fixation of an autologous graft which widens the urethra and promotes healthy epithelialization and healing, resulting in improved urine flow. TAURUS bridges the best of both worlds, by empowering urologists to treat strictures with greater efficacy and durability than current minimally invasive options (urethral dilation – mechanically widening the stricture, and urethrotomy – cutting the stricture), without the need for more invasive, open surgery and the associated risks. The use of a graft provides the benefits of urethral reconstruction, which is recognized to have significantly reduced stricture recurrence relative to the existing minimally invasive approaches. Minimal invasiveness makes our system less morbid than surgery and preferable to patients, and enables frontline urologists to deliver a durable, effective treatment option.
Our team has conducted preliminary tests in situ, and are performing preliminary tests in live animals to refine our device specifications. We expect to begin our formal ACUC approved rabbit study in the next month. The results of our rabbit study will inform our design and development of a dog study for transition to human scale. Through these activities, our team will be better positioned to develop an effective and durable clinical solution for urethral stricture disease, which can impact patients and empower urologists across the world.
Student Team: Saranga Arora, Ka Ho Cheung, Jourdan Ewoldt, Andrew Mao, Thomas Yi, Abhinav Harish, Eric Huang, Dahlia Rohm
Clinical Advisors: Viachaslau Barodka, MD, Muyinatu Bell, PhD, Steven Tropello, MD, Robert Allen, PhD, Nicholas Durr, PhD, Linda Liu, MSE
In the US alone, heart failure affects the lives of 5.1 million people and costs the healthcare system $32 billion a year. Cardiac output (CO) is considered the Dzholy graildz of hemodynamic monitoring because of its robust ability to reflect a patient’s cardiac function. Defined as the volume of blood the heart pumps per minute, CO provides an estimate of whole body oxygen perfusion and is thus a much neededparameter for patients at risk of heart failure. Clinicians use CO to improve fluid management and administer timely therapeutic interventions that can reduce patient mortality by 14%, morbidity by 30% and length of hospital stays by 10%. However, the clinical gold standard for CO monitoring, the pulmonary artery (PA) catheter, has significant complications associated with it such as arrhythmia, pulmonary infarction, thrombosis, vein tearing and infection. The PA catheter use has declined 65% in ICU patients because its invasiveness often outweighs the benefits of obtaining CO, limiting the number of patients that can be monitored. While other less invasive methods exist, they have not been implemented widespread because of significant shortcomings, such as high cost, high intra-operator variability and inaccuracy in critically ill patients.
CardiAcc has developed a noninvasive monitoring system based on scientific insight into a cardiovascular model that combines patient-specific data and noninvasive biosignals into accurate measurements of CO. CardiAcc’s integrated sensor system simultaneously measures multiple hemodynamic parameters, including pressure, acoustic and electrical waveforms. Preliminary retrospective studies at the Johns Hopkins Hospital have demonstrated that our CO values for healthy patients fall within clinically acceptable precision and accuracy thresholds. Unlike any other CO monitors, our method allows for low-cost, real-time, continuous, noninvasive and accurate monitoring of CO. CardiAcc’s mission is to bring CO monitoring to a larger number of ICU and OR patients, allowing clinicians to make timely interventions and improve patient outcomes.
Student Team: Arianne Papa, Bijan Abar, Emily Borst, Rajiv Deshpande, Vignesh Ramchandran, Christine Chung, Natalie Schmidt, Linh Tran, Victor Wang
Clinical Advisors: Dr. Myron Weisfeldt, Dr. Majd AlGhatrif
Faculty Advisor: Dr. Robert Allen
One of the aorta’s main jobs is to smooth out the pulsatile blood flow leaving the heart, a task made possible by the aorta’s elastic properties. With age, the aorta stiffens by many physiological mechanisms, and the increased aortic stiffening is a large contributor to heart failure.Despite a clear link between aortic stiffening and heart failure, there are no current heart failure therapies that directly target aortic stiffening as a root cause. As such, we have designed a novel intra-aortic device to re-introduce compliance into the system and restore the properties to those of a healthy, non-stiff aorta.
Our solution has two main components: an outer stent and an inner compliant biomaterial. The device is deployed like a stent, and the stent also acts to anchor the device to the aortic wall. The compliant biomaterial stores energy and is thus able to slow the pulsatile pulse waves associated with aortic stiffening. This design has been validated using a computational simulation, and we are currently in the process of constructing a to-scale prototype and testing the prototype in a physical model of the cardiovascular system.
Student Team: Antonio Spina, Himanshu Dashora, Michael Good, Jordan Kreger, Ronak Mehta, Sondra Rahmeh, Qiuyin Ren, Travis Wallace, Ryan Walter
Clinical Advisors: James K. Gilman, MD, MG USA (ret.), Kirby R. Gross MD, COL USA, Adam Dodson, NCEE, NRP, CCEMTP, Steven Tropello, MD, Vinciya Pandian, MSN, CRNP, Truc Nguyen, NRP, Matthew Levy, D.O., M.Sc., Keith Bernis
According to data from Operation Enduring Freedom (OEF) and Operation Iraqi Freedom (OIF), two of the most recent American military operations, 10-15% of preventable battlefield deaths were due to airway obstruction or respiratory failure. The increased use of improvised explosives and improved body armor in modern military engagements has led to an increase in survivable blast injuries, which often distort the anatomy of the primary airway. Therefore, airway management has become increasingly important in modern military medicine. To help reduce preventable deaths in the military due to failure to intubate, we have designed a handheld cricothyrotomy assist device to help combat medics (68Ws) perform the life-saving procedure on injured soldiers. At the moment, cricothyrotomy procedures, generally performed in combat settings, suffer from slow, outdated techniques and technology. Combat medics performing this procedure have a historical failure rate of 33%, while physicians and physician assistants have a failure rate of 15%.Often, combat medics do not have the experience or the confidence to perform the procedure quickly and effectively in the field, resulting in delays of treatment. Given that this is an emergency technique to maintain a proper airway, any delays in treatment or mistakes can be critical or even fatal. Through an innovative yet simple technique, the CricSpikeTM aims to eliminate the most common failure points of the procedure while increasing speed, user confidence, and therefore overall effectiveness at a low cost. A 68W performs a practice cricothyrotomy on a mannequin..
Student Team: Nisu Patel. Ernest Scalabrin, Karun Kannan, Kush Gupta, Larissa Chan, Mateo Paredes, Melissa Lin, Shayan Roychoudhury, Suraj Shah
Clinical Advisors: Abhay Moghekar, MBBS; Emad Boctor, PhD; Nicholas Durr, PhD; Andrew Malinow, MD; Anshuman Gupta, MSE; Arun Venkatesan, MD, PhD; Katarzyna Macura, MD, PhD; Rodney Omron, MD, MPH
To help physicians access structures and spaces deep in the body, we present EchoSpine, an ultrasound imaging device that delivers high resolution images inside the body at any depth. Deep needle placements are ubiquitous in the clinic and operating room. These types of procedures are used to make diagnoses, deliver therapies, and administer anesthesia for a variety of diseases and disorders. Examples include lumbar punctures, neuraxial anesthesia, central line placements, and needle biopsies.
Physicians often have difficulty correctly placing needles to access deep structures. First, the anatomical targets are typically very small and offer a tiny window for a successful procedure. For example, in lumbar punctures, the subarachnoid space is only 1-3 mm wide. Because the target is located deep in the body, typically 7-14 cm, accurate placement is incredibly difficult given the lack of visual feedback. Second, the path to the target is fraught with obstacles, including blood vessels, bone, and nerve bundles. Hitting these obstacles often results in increased complication rates and procedural failure. In addition to painful and dangerous complications, the result of puncturing a blood vessel or failing to access the subarachnoid space is a dangerous delay of diagnosis of acute central nervous system pathologies. Dangerous complications and delays are also demonstrated in many other procedures involving deep needle placements.
Therefore, there is a need for an improved means to access deep anatomical structures that reduces the number of attempts and the rate of iatrogenic complications resulting from blind access. EchoSpine is an ultrasound-imaging device that incorporates a PZT crystal at the tip of the needle. Using novel signal processing, EchoSpine generates an image of the surrounding tissue when the physician moves the needle. By visualizing the location of the needle tip with respect to obstacles and targets, physicians can dynamically guide the needle to avoid obstacles and reach the intended target.
Student Team: Shriya Awasthi, Miguel Dias, Kriti Jindal, Noemie Keller, Momin Mohis, Neil Rens, Micah Shaffer, Brooke Stephanian
Clinical Advisors: Myron Yaster, MD; Elizabeth Logsdon, PhD; John Lewin, PharmD; Katherine Vorvolakos, PhD; Caleb Alexander, MD; Robert Allen, PhD; Nicholas Durr, PhD; Youseph Yazdi, PhD, MBA
There are over 16,000 deaths annually from prescription drug overdose, resulting in over $72 billion in costs for medical providers, insurers, and the government. The lack of disposal methods for excess prescription opioid pills is a key contributor to what the CDC says is an epidemic of painkiller abuse. 65% of new initiates to nonmedical prescription drug use obtain their pills from friends or family. This is made possible by the over-dispensing of opioids with ⅔of these pills left unused by the patient to whom they are prescribed. Most existing solutions, such as Naloxone, focus on patients who are already addicted to opioids. However, this is corrective rather than preventative; such solutions do not prevent new initiates to abuse nor do they address the risks associated with users leaving their pills unattended long after the prescription expires. While there are some opioid deactivation products on the market, users must purchase them separately from their pills (often at another location). Users must actively and voluntarily acquire these products, an investment of time and money, and then carefully follow multistep instructions to successfully deactivate their pills.
DTX created an innovative pill bottle that automatically deactivates prescription opioids. After the prescription period ends, our product automatically mixes the pills with a solution that chemically deactivates the active compound in pills. The resulting mixture is safe to ingest or dispose of in the trash. We have refined and validated our deactivating solution and are currently working to integrate it with our low-cost, unobtrusive pill-bottle design. Once deployed, our pill bottle will contribute to curbing the epidemic of abuse by reducing the number of leftover pills vulnerable to abuse.
Student Team: Rowan Cade, Tom Bernstein, Emily McNally, Kevin Moon, Brooke Mahoski, Lexie Scholtz, Zhou Li, Sue Min Cho
Clinical Advisors: Scott Paul, MD, Robert Allen, PhD, Michelle Zwerneman, MSE, Anita Stone, MS, HEM
Healthcare workers, particularly nurses and nursing assistants, endure some of the highest rates of occupational musculoskeletal injury and the most missed workdays due to these injuries. Patient-handling events, including lifting, repositioning, and transferring, result in a third of the total number of lost workdays. Hospitals face significant monetary ramifications that arise from these injuries. Considering only neck, back, and shoulder injuries among nursing assistants, registered nurses, and licensed practical nurses, hospitals spend $1.5 billion annually on affected healthcare workers’ compensation, lawsuits, and medical bills.
Compliance is the key issue here. Although there are lifts available for use, they are bulky and time consuming, and therefore inconvenient. For these reasons, nurses often opt for manual transfer, at which point, the nurse is at risk for musculoskeletal injury. Biomechanically, there is no way to manually transfer a patient without putting the nurse at risk for injury, regardless of their technique or posture. To address this, a solution must complete the transfer process promptly, be intuitive and convenient to operate, and be easily accessible to integrate seamlessly into the normal hospital workflow.
With the aforementioned requirements in mind, we developed our device, exoRise, a sit-to-stand patient transfer assistive device in the form of coupled knee braces that are placed on the patient to augment their own strength. Our prototype is small in size, permitting ease of use, and features a quick and simple attachment system. The two braces are fixed to the patient via ratchet straps, which are mounted on adjustable cuffs to fit a variety of leg sizes. The cuffs fit to a lightweight frame featuring behind-the-leg supports that distribute the pressure on the legs during transfer. The frame houses two linear actuators per brace. The linear actuators act on a lever arm to apply torque only about the knee in order to cause the patient to rise from sitting to standing. The linear actuators are connected and controlled via one Arduino control system. We plan on testing our device with mechanical bench testing of the prototype and user interface testing with health care workers as participants, pending IRB approval. Because of its f ocus on empowering the patient and encouraging nurse compliance, exoRise stands out in the crowded field of patient transfer devices as a solution that is not only effective but will be widely adopted and used in a clinical setting.
Student Team: Doran Walsten, BaDoi Phan, Kendrick Hougen, Kyoung-A Cho, Ron Boger, Kevin Zhu, Patrick Myers, Teja Polisetty
Clinical Advisor: Nicholas Mahoney, MD; Nicholas Durr, PhD; Patrick Byrne, MD; Austin Reiter, PhD; Alison Wong, MD; Ben Kutil
flapp is a mobile computer-assisted surgery application that will help surgeons create and plan local tissue flaps in facial reconstructive surgery. Local tissue flaps are a common method to close an open wound on the face. During the procedure, skin near the wound is incised and then repositioned to cover and repair the defect site. When properly done, the defect repair is close to unnoticeable. However, the consequences of improperly designing a flap can lead to severe medical and aesthetic complications. Local tissue flap design requires a great wealth of medical information, surgical expertise, and case-by-case consideration on the surgeon’s part, thus making it a challenging procedure for surgeons.
flapp provides an interface for surgeons to view multiple flap designs on a 3D reconstructed image of a specific patient. The 3D surface represents an improved shape and geometry of the face compared to a traditional 2D image. For a chosen design, flapp would provide tension and strain feedback. The surgeon can then make edits to the design based on this feedback and improve the outcome their procedure. These features allow surgeons to determine the flap that would result in minimal medical and aesthetic complications.
Technological tools are currently available and in development for assistance in surgery, but are not implemented for the design of local soft tissue flaps. These tools implement features that are useful to flap design, such as patient specificity, 3D imaging, mobility, and skin tension feedback. However, no one technology integratesall of these features together. flapp has the potential combine these features onto one platform and be a useful tool to help surgeons make informed decisions on flap designs. Novice and inexperienced surgeons will be able to quickly learn how to make challenging flap-design decisions that currently require many years of operating experience to grasp and master. The ultimate goals of flapp are to raise the quality of life for patients following surgery, assist in the training of surgeons, and reduce the logistical burden on surgeons performing flap surgeries.
Student Team: Yu Xu, Kaiyuan Wang, Ana Ainechi, Michael Ruiz, Andie Seabrooke, Pooja Nair, Najwa Faqih
Clinical Advisor: Alexander Hoon, MD, MPH, Tara Johnson, MD, Brittany DeCroes, PT, DPT, Robert Allen, PE, PhD
Scissor gait is one of the major challenges affecting mobility in individuals with cerebral palsy (CP), which is a neurological abnormality accompanied by many movement disorders. Scissor gait is characterized by the crossing of the legs in a scissor-like movement during walking. The symptoms of scissor gait include crouching, severe adduction of the legs, and hitting of the knees and thighs. In the United States alone it is estimated that nearly 80,000 individuals with CP are affected by scissor gait.
We developed a novel orthosis, called GaitAssist. GaitAssist utilizes two connected blocks that are placed in between the thighs as a physical barrier to separate the legs. The blocks are strapped onto each thigh, and connected by a metallic bolt so the two blocks can easily slide along each other during the gait cycle.
To validate the two-block design in terms of separating the legs and improvement of balance, we planned a clinical trial with ten patients with GMFCS levels 1-3. This study is underway and we currently have processed quantitative data for the first two patients. Both patients show significant increase in base of support. Both patients’ swing phase percentage was closer to the percentage seen in a typical gait cycle with GaitAssist, indicating improved posture and stability.
Student Team: Sanjay Elangovan, Alwin Hui, Nikhil Jois, Yechan Kang, Ben Lee, Sarah Lee, Monica Rex, Bailey Surtees, Sonia Traku
Clinical Advisors: Susan Harvey, MD, Nicholas Durr, PhD, Youseph Yazdi, PhD, Kelvin Hong, MD, Su Lucas, MBBCh, Kristy Peterson, Richard Hughen, MBA
Breast cancer is a growing problem throughout the world. However, in recent years, as more developing countries begin to adopt Western lifestyles, the incidence of cancer has begun to rise in low and middle-income countries, particularly in rural areas. In South Africa, most rural women do not have ready and affordable access to proper treatment, as those diagnosed have to be referred to regional hospitals, which are farther away. The high costs often cause women to delay treatment, or discourage them from seeking out treatment at all, which leads to high mortality rates and lowered quality of life. Over 78% of women in South Africa are not diagnosed or treated until the cancer has already metastasized. With a current five-year survival rate of just 40-50%, we see an opportunity to make a strong impact in the lives of rural women in South Africa and other low and middle-income countries by developing a low-cost treatment that can be delivered by physicians in rural clinics in order to increase the accessibility of treatment to reduce mortality and increase the quality of life for these women.
Our solution is a cryoablation device that utilizes carbon dioxide, a gas that is readily available in most low and middle-income areas. By harnessing the cooling power of the Joule-Thomson Effect, we aim to freeze and kill cancer cells. Cryoprobes commonly used in the United States, which generally use argon gas, cost upwards of $2000 and are not reusable. Our innovation not only aims to utilize gas that is available in the targeted areas, but also to be autoclavable, thus making cryotherapy affordable and accessible for these patients. Using this probe, we hope to be able to greatly decrease the cost of cancer treatment and increase its accessibility.
Student Team: Paola Donis, Joe Hakim, Daniel Huang, Gabriela Rodal, Tam Thanitcul, Yuan Hao Wong, Justin Yan, Yu Zhang
Clinical Advisors: Elizabeth Cristofalo, MD, Sridevi Sarma, PhD, Kristy Peterson, Robert Allen, PhD, Soumya Acharya, MD, PhD
Every year, there are 4 million neonatal deaths around the world, predominantly in low and middle income countries. One of the leading causes of these deaths is sepsis, which is a systemic inﬂammatory response to infection. Half of home delivered neonates succumb to sepsis and severe infections, indicating the magnitude of the issue. Despite efforts to move deliveries from homes to medical facilities, more than 70% of women in the two poorest wealth quintiles still deliver at home in developing countries within Sub Saharan Africa (SSA), South Asia, and Southeast Asia. In addition, neonates are discharged from the hospital as early as six hours postbirth, when their immune systems are still weak. Families in these regions depend heavily on community health workers (CHWs) to perform routine screenings for their neonates, but such screenings are for physical symptoms of general diseases and are unable to capture early signs of neonatal sepsis. Failure to rapidly detect serious neonatal infections during home care immediately after birth delays treatment, and leads to increased morbidity and mortality. Studies have shown that each hour in delay of treatment results in an approximate twofold increase in mortality rate.
The aim of our project is to achieve early risk assessment of neonatal sepsis. NeoSED is a homebased sepsis risk detection system that analyzes heart rate characteristics to output a highly sensitive sepsis risk score. NeoSED ﬁts into the current CHW system and technological infrastructure of developing countries it features automatic data processing which allows for greater compliance, and utilizes text messages to seamlessly transmit data regarding the neonate’s status to the CHW. The NeoSED system consists of a worn device called the SepSock that houses the processing unit, heart rate sensor and user interface components. The SepSock is to be worn around a neonate’s foot semicontinuously for the ﬁrst week after birth and will collect heart rate data. That data and patient history information will then be processed in situ by an algorithm, to produce a SepScore which indicates the probability that the neonate will develop sepsis. Parents can periodically send the SepScore to CHWs by plugging in their basic mobile phones to the worn device; if the score exceeds a certain threshold, an alarm message will be sent to the family members, thereby prompting them to seek critical earlier treatment.
We are conﬁdent that NeoSED has the potential to drastically reduce delays in treatment for septic neonates. On a large scale, this system may prevent hundreds of thousands of neonatal deaths due to sepsis and stands to have a great global impact.
Student Team: Kunal Patel, Rebecca Glowinski, Jon Hochstein, Jeffery Li, Manyu Sharma, Domonique Carbajal, Robert Dembinski, Shravya Gogula
Clinical Advisors: Nicholas Durr, PhD, Soumyadipta Acharya, PhD, MD, Azadeh Farzin, MD, MPH, Estelle Gauda, MD
Neonatal intensive care units (NICUs) in developing countries are overcrowded and healthcare providers are overworked.Monitoring vital signs is a time-consuming process that nurses often do not have the time to perform for every patient in the NICU.Gold-standard vital signs monitoring equipment is too cost prohibitive to be used in low resource settings. Because of this shortage of manpower and lack of quality monitoring equipment, there is a serious risk of neonatal distress going unnoticed. We are working to develop a low-cost vital signs monitor system that will increase the effective manpower available in low resource settings without having to increase the actual number of healthcare workers available. Our system, NeoVate, is made up of three components:
This system will allow nurses to be more efficient in their workflow and maximize the utility of their medical expertise. Rather than constantly performing the time-consuming activity of measuring vital signs, they can focus their direction to the patients who need it the most.
Student Team: Caitlin Romanczyk, Clay Andrews, Josh Punnoose, Quinn Salditch, Scott Sterrett, Zack Buono, Paige Frank, Ananya Gupta
Clinical Advisors: Peter V. Johnston, MD; Chao-Wei Hwang, MD
Cardiovascular disease is the leading cause of death globally and the most significant cost contributor to the health care system. The underlying cause of the vast majority of cardiovascular disease is coronary artery disease, which is the buildup of plaque in the blood vessels that supply the heart. These occlusions obstruct blood flow, causing angina and often leading to heart attack. For cases in which there is minimalcalcification of coronary occlusions, balloon angioplasty and stent placement are effective in restoring blood flow. However, as coronary plaque calcifies over time, the vessels become too rigid to expand through these methods.
Currently, heavily calcified occlusions are treated with an aggressive intervention known as coronary atherectomy, which modifies the compliance of the plaque so that angioplasty can be successfully performed. The current standard of care for this procedure is Boston Scientific’s Rotablator, which is an abrasive burr that drives through calcified occlusions while rotating at 180,000 RPM. This procedure can be incredibly dangerous and is characterized by a 3 to 5% rate of vessel perforation and dissection, which occurs when the arterial wall is torn or punctured. These complications lead to heart attack and internal bleeding, frequently necessitating emergency cardiac surgery.
Plaqate is developing an atherectomy device to safely and effectively treat patients with advanced coronary artery disease. Our device operates on the principle of differential cutting, allowing the interventional cardiologist to preferentially ablate hard plaque while leaving the more pliant vessel wall intact. This will allow interventional cardiologists to effectively target calcified coronary occlusions with significantly reduced risk of downstream complications and major adverse cardiac events.
Student Team: Priya Arunachalam, Gabriela Frid, Ravi Gaddipati, Angela Park, Kamran Siddiq, Darius Tolberta
Clinical Advisor: Chetan Bettegowda, MD, PhD, Tomas Garzon-Muvdi MD, MS
Hydrocephalus is a condition characterized by a buildup of cerebrospinal fluid (CSF) in the ventricular cavities of brain.The condition is mostcommonly treated with a ventricular shunt;acathetercontinually drains CSF from the brain.Of the approximately 40,000 shunts placed each year, more than 80% fail within 10 yearswithmore than 50% of these failures dueto obstruction of the catheter fromchoroid plexus growth into the catheter.As a result, patients must undergo,on average,2.7revisionsurgeries throughout their lifetime.
Sureshuntaims to solve this problem. Unlike the current catheter, Sureshunt uses the ventricular anatomy to its advantage.The lateral ventricle, the most common target for a ventricular shunt, consists of an oblong cavity within the brainwith choroid plexus lining the floor of the ventricle.When the current axial catheter is placed, the drainage ports are exposed to the choroid plexus, and subsequently blocked by choroid plexus infiltration.With its novel design, Sureshunt is able to prevent contact between the drainage ports and the choroid plexusdue to itscharacteristic shielded configuration. With its ability to collapse into the standard form factor, a straight pointed tube, Sureshunt can be inserted just like the current catheter. With little change in procedural workflow, surgeons are able to safely insert the catheter while ensuring long-termfunctionality. Therehave been several attempts at a solution, including a flanged ventricular catheter and a coiled catheter introduced in 1976.However, these catheters only delay the time between initial growth and revision, increasing the patients risk of hemorrhage and are not currently used for this reason.Sureshunt is able to increase the functional lifetime of the catheter while increasing patient safety.
Student Team: Amy Sun, Lucy Han, Monique Bailey, Christine Yu, Kevin Huang, Celine Arpornsuksant, Christopher Sears & Jeesoo Kim
Clinical Advisor: Zoltan Mari, MD; Robert Allen, PhD; Yousef Salimpour, PhD; Youseph Yazdi, PhD, MBA; Soumyadipta Acharya, MD, PhD; Chad Schneider, PE
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 a 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 (DBS), an expensive and invasive surgical procedure with strict eligibility criteria. This leaves a significant number of patients without an effective intervention.Thus, patients with PD, for whom medications are no longer effective and for whom DBS is not an option need an alternative treatment method in order to alleviate motor symptoms and increase accessibility to treatment.
Tremtex is developing a product, called STIMband, which will work in conjunction with medication and will facilitate therapy at home. STIMband implements transcranial direct current stimulation (tDCS) technology as a non-invasive solution that addresses the needs of PD patients by delivering small amounts of current to the motor cortices through electrodes. Multiple research studies have established safety for tDCS and suggest that it results in the reduction of motor symptoms and thus improved quality of life for PD patients. The value of STIMband is that it brings effective interventions to PD patients in the comfort of their own homes without compromising safety or usability. Tremtex is currently refining the design and conducting testing for iterations of STIMband and will begin human factors testing over the summer with an IRB.