Project types: GH indicates Global Health | MT indicates MedTech
Acute spinal cord injury (SCI) is presented in two phases – primary phase of mechanical trauma and secondary phase, chronic, local hypotension. SCI presents itself in 17,000 new cases per year. Less than 5% of patients afflicted with acute SCI with Grade A injuries exhibit improvement. Patients of SCI can be subject to tetraplegia and paraplegia. Blood-flow abnormalities can be indicative of hemorrhage, hypoxia, cyst formation, and glial scarring. There is currently no standard to measure blood flow in the spinal cord. The ability to monitor mean arterial pressure (MAP) may serve as a pivotal measure to treat and to prevent the aggregation of such clinical issues.Patients that suffer from high tetraplegia can incur over a million dollars in the first year, while patients with low tetraplegia and paraplegia may incur $800,000 and $500,000, respectively. Costs are incurred from the spinal surgery, rehabilitation, medication, medical equipment, and long-term care. Effectively monitoring the SCBF can lead to a reduction of the rate of paralysis and other clinical issues indicative of abnormal blood flow and can be used to determine recovery. While the target population is 17,000 patients, the foreseeable implications of an intraoperative blood flow monitor that could extend beyond SCI and may be used for other traumatic injury procedures. However this will be our primary target reach. A reduction of costs and improving the quality of life for patients can be expected with a viable solution. Patients need a solution in order to mitigate further clinical issues characteristic of abnormal blood flow. Clinicians require an ergonomic, portable method of measurement that can be used in the operating room. The solution scope for this project spans imaging techniques, sensors, etc. Viable directions of investigation include piezoelectric-polymer films MRI optical imaging and ultrasound, as explained by Dr. Theodore. To validate and determine the accuracy and random error of our developed method, microspheres can be used as a reference. These published sources along with the resources that we will have available provide proof of feasibility.
Current feeding tube attachments are designed to sit between the inside of the stomach
wall and the surface of the skin. To insert a device into this stoma length, there are currently two different methods. The first method uses an inflated balloon and additional tubing to span the distance of the stoma length. The other method uses a supply of varying tubes that can be inserted after measuring the appropriate size for patients. Dr. Weiss would like to combine the aspects of each, while eliminating extra material that are hindrances to both patients and physicians. Merging the components of these two products would also eliminate excess supplies. Our goal is to create a solution that would be priced competitively to the current feeding tubes. The original tubes, which are usually replaced 1-2 years, will eventually be phased out of production in favor of a solution that could cut hospital inventory in half.
With more than 100 thousand procedures of PEG tube replacements within a year and half a million people who have feeding tubes, patients and physicians would benefit from a new device to reduce the time and costs of feeding tube replacements. Over extended time, the stoma length enlarges, causing the need for a replacement. Another problem faced by physicians are the rapid growth of their pediatric patients. This growth requires their feeding tube to be constantly adjusted and changed. Both issues can be addressed with an adjustable stoma, reducing the number of times patients would have to visit the hospital for a tube replacement. Minimizing patient visits will also increase physician and hospital efficiency.
A fistula is defined as an abnormal connection between two organs. Some examples of common fistulas include ones formed in the urinary tract, anal cavity, and intestines. They typically develop as a result of infections, inflammations, childbirth, injuries, or surgeries. Once a fistula is formed, it eventually becomes lined with endothelial or epithelial cells, which makes it difficult for surgeons to close up the tract. If left unplugged for an extended period of time, fistulas can cause severe infection, nerve damage, and kidney disease. There are an estimated 50,000-100,000 new cases of fistulas every year. There currently is a method to close the fistulas (biosealant), however delivering the biosealant to the desired location and keeping it at the fistula is difficult and imprecise.
Fellows and medical students need a risk-free way to practice high-stake surgical procedures in order to boost trainee confidence and minimize surgical errors.
Clinical Impact- There has been a paradigm shift in the field of medicine from the perspective of training incoming students and practitioners. Medicine is one of the few domains where no practice is performed before a high-stakes event surgery. For instance, is a surgeon able to practice a particular cardiac surgery before it is to be done? The impact of this lack of practice is significant, especially in the case of rare conditions with few surgical instances. The current method of training occurs through apprenticeship where the students and fellows observe the physician performing the surgery and then practice on the patient himself. To avoid potential complications in such a scenario, simulation-based training has been proposed as an alternative. This would occur through the use of a VR headset and associated handheld devices (that provide tactile feedback) that incorporate specific surgeries physicians are about to perform. Not only can physicians practice an unlimited number of times, but they can do so in a low-risk environment. This shift will increase confidence amongst inexperienced trainees, decrease patient exposure to potential surgical errors, and ultimately improve their outcome. Technical Feasibility – this project would require the creation of a virtual-reality based game, one in which surgical simulations can be performed. Given that VR is not a typical medium we currently encounter in our daily lives yet, issues that arise in terms of software will be more difficult to solve due to the minimal information online relative to other mediums. Furthermore, this would require the members and the leader to learn an entirely new system (Unreal 4 is the software usually used for the generation of VR games). Although it may seem daunting at first, there are tutorials online, and free software that can be used to build such a platform. It will be a challenge, but definitely one the team is looking forward to tackling.Commercial Opportunity – there are various competitors out there creating products which are not entirely similar to this concept. For instance, VirtaMed has a product that allows physicians to practice endoscopic procedures using real surgical tools (Medical Training Simulators, 2017).
Another potential competitor is zSpace which offers medical education through virtual learning. However, this is simply a way to visualize anatomical structures without any interaction with them. The beauty of such a project is its instant appeal and demonstration capabilities. At business plan competitions, one can test the VR headset on the spot and show the results, therefore generating a large impact amongst the judges. Furthermore, the change in regulation of the American Society of Radiology to simulation-based training, in addition to the Chief of Radiology at Hopkins Hospital being a strong supporter of such a VR system implies that we will have strong support and credibility in this field.
Hydrocephalus is the buildup of cerebrospinal fluid in the ventricular system that must be
flushed out, or it will cause serious health related issues and even morbidity. It occurs in
1.5 out of every 1000 births, and is particularly dangerous for young children.1 The current standard of care to flush out this fluid is to implant a shunt, connecting the ventricles to the peritoneal cavity, and depositing the CSF there, where it is reabsorbed. However, the device has a malfunction rate of 12.9% after 30 days, and 28.8% after one year.2 A malfunction in the shunt system can prove to be either deadly or permanently scarring for a patient, and there currently is no method to noninvasively monitor this commonly used device. The potential impact of a malfunction detection system would be to provide access to previously unavailable flow data along the extent of the shunt line. Therefore, the device, if implemented in all hydrocephalus shunt cases as a new standard of care, would be able to provide data for all types of current shunt designs. This would also have a significant clinical impact, in that diagnosis would be streamlined and, after collection of baseline data, be achievable via machine learning algorithms for each patient. By eliminating the need for comprehensive, often time-intensive, expensive tests, patient risk would be minimized, while clinicians could more efficiently identify and rectify a blockage. Therefore, a shunt monitoring device would have a large market and clinical impact.
Traditionally, clinicians keep children in critical condition in the pediatric intensive
care unit (PICU) constrained to their beds. However, extended periods of immobilization in ICUs have been associated with various impairments of physical functioning and neuromuscular weakness, which can occur in 25% to 50% of ICU patients. Furthermore, pediatric patient immobilization can have adverse effects on the mental and emotional well-being of the patient and the patient’s family.
Fortunately, studies have shown that early mobilization can significantly reduce the negative physical effects of intensive care unit stays in adult and children populations. Early mobilization has also been linked to decreased length of stay in the intensive care unit. Since the average cost of treatment in the PICU can exceed $9,000 per day at many hospitals, early pediatric mobilization can lead to a notable reduction of healthcare costs. Additionally, research shows that early mobilization is generally safe and feasible for adults with the right equipment. Data collected from the Johns Hopkins PICU corroborates these results and found that there was a 0% adverse event rate across 200 cases of early pediatric mobilization. Although early pediatric mobilization is safe and has numerous proven benefits, no pediatric-specific walking equipment exists to help children achieve early mobilization. This is likely due to the large height and weight variability among pediatrics. Among the 53 institutions participating in the PICU-Up early pediatric mobilization program, none posses equipment to assist in early mobilization for pediatrics. This is highly unfortunate, considering that approximately 250,000 children are admitted to PICUs each year. Two major obstacles that must be addressed to allow for wider PICU mobilization are that critically ill children often have multiple assistive technologies and monitoring devices that must be tethered to them, which makes it difficult to transport the patient, and that children can vary greatly in height. Dr. Kudchadkar would like for us to develop adjustable equipment that would allow for critically ill patients between the ages of 6 and 12 to walk around the intensive care unit, while effectively managing their attached assistive and monitoring equipment.
Hearing loss is prevalent in the United States, with around 1 in 5 Americans over the age
of 12 having some hearing loss, adding up to a total of 48 million Americans being affected.1 Hearing loss affects quality of life adversely, resulting in greater risk of dementia, falls and depression. Receiving hearing care is a complicated process due to the process-‐heavy system. Medicare doesn’t cover a hearing test unless it was referred to a patient by their primary health care provider. Ideally, a patient would receive a hearing screening, which would inform the primary care physician if they had a hearing loss, and if this loss was mild, moderate or severe, and then the primary care physician would refer them to an Audiologist or ENT. Shockingly, 89% of adults over 65 with hearing impairments say that their primary care physicians had never screened them for hearing loss or asked about their hearing health.5 This seems to be because patients usually present to a primary physician for other conditions unrelated to their hearing, and there is no time for the physician to inquire or screen for hearing health. However, in this same setting, nurses regularly conduct quick tests for blood pressure and general height/weight. Many authorities on the subject are recommending hearing screening be done at this primary stage in order to reduce the burden hearing loss places on people as well as insurance companies and the healthcare system. Having mandatory hearing screening at the primary healthcare stage requires a quick, cheap and easy screening tool.
Surgical resection of deep brain lesions requires careful planning and execution to avoid iatrogenic neurological injury. Brain retractor systems have existed for decades to perform tumor removal procedures, despite being known to result in brain swelling due to extensive force applied onto nervous tissue. Regardless, surgery with metal fixed retractors remains the most commonly used standard for treatment. While progress has been made in minimizing fiber tract trauma through the development of commercial tubular retractors that apply radial force to tissue, challenges remain for surgeons using these instruments. Noted design complaints include long operative reach for surgeons, limited corridor for bimanual procedures with existing forceps, aspirators, and bipolar cauterization tools, as well as poor visualization of the tumor site through the channel. Compounded with poor training programs and clinical support, these limitations have resulted in slow and skeptical adoption by neurosurgeons. There is a need therefore to develop a retraction system that caters towards these surgeon preferences without compromising patient outcomes.
In normal infants, the major pieces of the cranial bones are not fused together in order to allow the brain to develop in size as the child grows. However, in craniosynostosis, these cranial sutures fuse prematurely, resulting in abnormal head shape and restricted growth of the underlying brain. While in most cases the brain functions properly, the child experiences significantly decreased HRQOL due to the elongated head shape (scaphocephaly). Sagittal craniosynostosis occurs in approximately 1/1000 infants and the case incidence is about 1~2 cases per month at JHH. Traditionally, invasive surgical techniques were used, whereby the entire portion of the head above the sutures is cut open. Recently, there has been a shift towards a minimally invasive approach, which requires only 1 or 2 incisions and an endoscope. However, the current piezoelectric craniotomy device is not optimal for the minimally invasive technique. The procedure can potentially be done faster (1hr —> 20min) and safer (preventing tearing of dura mater underneath the skull) with the development of a more suitable device.
In the US, hemodialysis is the standard of care for adults with end-stage kidney disease, but most
children receive at-home peritoneal dialysis (PD) because it better regulates the child’s
electrolyte balance and allows them to attend school. However, PD comes with a high risk of touch contamination at any of the labeled connection points (Figure 1). These small contaminations require immediate antibiotic treatment, but oftentimes providers do not realize when contaminations occur, which leads to peritonitis. Over $20 billion per year in both private and Medicare dollars is spent on treating infections due to dialysis. In addition to these huge healthcare costs, reducing the risk of touch contamination and the incidence of peritonitis will also improve the quality of life of patients. More adults would go on PD and thus they would generally feel better and would not have to miss work for hemodialysis treatments, which last 3- 4 hours per session, 3-4 times per week.
In addition to the clinical benefits of this project, there also exists a large commercial opportunity. There have been some attempts at solving this need; one such device was Puracath Firefly, which is an extra connection piece, but parents and providers did not accept it, as it added extra steps to an already complex at-home procedure. Fresenius also makes devices for CAPD (continuous ambulatory peritoneal dialysis) that works to minimize touch contamination, but this device is cumbersome and is not made for standard PD and most patients prefer to only be connected to dialysis machinery at night. There have also been papers published about PD infection; one interesting project discussed using antibiotic creams and found positive results, but this is not being implemented (I asked Dr. Neu about the reasoning for this). In addition, Dr.Neu’s organization, SCOPE, is primarily looking at ways to reduce infection caused by hemodialysis, so there is currently no one looking into peritoneal dialysis efforts. This is an extremely opportune time to approach this issue because in the very near future, there will be more work going into PD infection prevention. Thus, now is the time for the greatest commercial opportunity.
Lastly, the project seems to be very technically feasible. There exist many ways to prevent bacterial contamination, and this project requires some knowledge about the PD machine and processes, but does not require extensive knowledge of a foreign idea, nor does it seem to require extensive out-sourced skills/manufacturing. Need Statement: There is a need to reduce the likelihood of connector contamination in at-home peritoneal dialysis systems in order to reduce the incidence of peritonitis and improve the quality of life of kidney-failure patients by enabling more patients to receive peritoneal dialysis.
Need Statement: There is a need for a method to reduce the loosening of casts that occurs due to shrinkage of padding and atrophy of muscle to improve the healing of fractures, prevent the need for recasting, and reduce time and costs to patients and physicians.
Project Summary: Approximately 887,679 hospitalizations result each year from fractures in the U.S. alone. Current casting methods are inexpensive but also ineffective. Most casts utilize either fiberglass or plaster to form a rigid structure, paired with cotton or gore-tex padding in order to stabilize the fractured bone. After bone fracture, severe swelling of the extremity can occur. Once this swelling subsides the cast cannot conform to the smaller shape of the extremity. Additionally, after long periods of immobilization muscle atrophy can cause the cast to loosen. This loosening causes slippage, skin irritation, loss of fracture stability, and even premature removal of casts by patients, all of which can slow or prevent proper healing.
The cotton padding that is currently used can contribute to loosening because after time it can compress due to moisture, from outside water or from sweat, and it can pick up grime causing irritation of the skin. Gore-tex padding is designed to be “waterproof”, however it still compresses significantly over time and is not immune to causing skin irritation or developing a smell. Currently the standard of care is to recast the patient about 3 weeks after the initial cast was applied. Physicians only receive one payment for this entire process, usually including at least one recasting. Additionally, depending on the severity of swelling and the type of fracture, it may not even be possible to cast until several days after the injury due to the risk of compartment syndrome if swelling increases at all and the cast becomes too tight. A new cast design that has the ability to adapt its fit throughout the treatment process could eliminate this need for recasting saving time and money on both the patient and physician end. The potential cost savings as well as the value added to both customers and physicians suggest a solution would be commercially viable.This newly envisioned cast design could take on a number of different forms, however due to the understanding of both the need and current solutions and the relative simplicity of the
current cast designs the project seems very technically feasible.
More than a quarter of children admitted to the pediatric intensive care unit have or go on to develop pediatric multiple organ dysfunction syndrome (MODS). The current process for diagnosing MODS takes almost 24 hours — coupled with the fact that organ failure catastrophically impacts patient outcomes, the slow process of MODS diagnostics means the mortality rate is 10-57% in the ICU. The team will be working on developing a classifier capable of predicting MODS from a wealth of existing clinical data. ICU patients are heavily monitored, but there is no automated, scalable application that uses this captured patient’s data to accurately predict the likelihood of developing MODS in real time. We have access to existing the historical data from the physioCloud database that Drs. Winslow and Sarma have used to train a similar classifier for sepsis. The goal of the project would be to build a suitable classifier capable of detecting MODS in real time, and then building a suitable user interface to communicate results to doctors in the ICU.
Convection-enhanced delivery (CED) is a promising technique that generates a
pressure gradient at the tip of an infusion catheter to deliver therapeutics directly
through the interstitial spaces of the central nervous system. CED is a broadly applicable technique that can be used to deliver a variety of therapeutic compounds for a diversity of diseases including malignant gliomas, Parkinson’s disease, and Alzheimer’s disease. Key features that can be improved in a novel CED device (compared to previous devices) include a better design for reliable safe housing of the CED device catheter and clear and customized cranial implants for better visualization and wireless communication. But perhaps the biggest improvement would be a portable system residing completely within the scalp. We propose a battery-powered custom cranial implant drug delivery system utilizing CED. The success of this project will have significant impact in the fields of neuro-oncology and brain tumor disease, in addition to diseases mentioned above.
In terms of technical feasibility, we believe this project is feasible for a design team and has many pathways for a solution. A solution will most likely involve the use of microfluidics to transport and store the therapeutic drugs, thus significant background literature already exists. Challenges of a solution include ensuring that fluid inside the body does not contaminate or seep into the implant, and that the implant can effectively and accurately deliver drugs. Both challenges can be evaluated in a prototype through preliminary mechanical testing (e.g. submerging the implant in liquid with a similar viscosity to blood within the scalp) before moving on to animal testing. In addition, a solution
In terms of commercial opportunity, the market is sparse. Any CED devices that have been previously developed have failed at clinical trials, lacking the key features listed above. Since the final product for this project would be adding to the initial implant Dr. Gordon’s team created, it is a one of a kind solution with zero competition. The overall product – Dr. Gordon’s implant and our solution – will be solving a need in a market with no major competitors or developments.
Needs Statement: There is a need for a portable cranial implant drug delivery system utilizing Convection-enhanced delivery in order to adequately deliver therapeutic drug compounds through the interstitial spaces of the central nervous system to treat CNS diseases and disorders.