Johns Hopkins University

NCIIA-funded course at JHU generates new biomedical start-ups

A 2010 course and program grant awarded to Center of Bioengineering Innovation and Design (CBID, itself supported by an NCIIA Course and Program grant) at Johns Hopkins University has swiftly returned on its investment. Two biomedical device start-ups have spun out of the Master's Level Education in Bioengineering Innovation course:

Grant PI Bob Allen reports that so far 15 students have graduated from the program with MS degrees. JHPIEGO, JHU’s global health partner, is further developing two other projects from the grant: an electronic partogram and the antenatal screening kit (a 2010 E-Team grantee and Popular Science invention of the year).

 

Antenatal Screening Kit E-Team part of $24 million global health innovation project

An NCIIA grantee, the Antenatal Screening Kit team from Johns Hopkins University, will be part of a five year program to address global health challenges through affordable technologies.

Jhpiego, a global health nonprofit organization affiliated with Johns Hopkins, will lead a $24.9 million effort to expand its array of simple inexpensive lifesaving technologies to address today’s global health challenges.

In 2010 the Antenatal Screening Kit team received a $16,000 E-Team grant to develop a simple self-screening test for diseases such as pre-eclampsia/eclampsia, the second-leading cause of maternal deaths worldwide.

More about the team:

Pop Science selects Antenatal E-Team 'pen' as Invention of the Year


 

Since being selected to attend this year's Open Minds showcase in March, the Antenatal Screening Kit E-Team from Johns Hopkins University has earned a growing media following.

The team's invention, a suite of pens that can be used to screen expectant mothers for treatable diseases and health problems, has been featured in Popular Science's 'Invention of the Year' issue (June 2011, page 62).

The team was also featured in the JHU Gazette -- read the story here.

 

 

 

  

 

 

New E-Team - Antenatal Screening Kit - wins ABC/Duke Reinventing Maternal Health Challenge!

One of NCIIA's most recent E-Teams, the Antenatal Screening Kit team from Johns Hopkins University, has won the inaugural ABC/Duke University 'Reinventing Maternal Health Challenge.' The Challenge was devised in partnership with The Lemelson Foundation.

The JHU team has developed a screening kit - delivered through a pen - to provide low-cost healthcare to women in even the remotest villages. The kit includes a variety of custom markers pre-filled with reagents for screening tests for conditions including pre-eclampsia, gestational diabetes, malnutrition, and anemia.

Selected from more than 65 video entries submitted by university students internationally, the JHU team will be awarded $10,000 and will be provided mentoring and support from The Lemelson Foundation.

 

Minimally Invasive Device for Harvesting Iliac Crest Bone Graft

Johns Hopkins University, 2010 - $20,000

There are over 1.5 million spinal fusion surgeries performed annually worldwide. Bone grafting is the standard practice in orthopedic medicine to foster restoration and healing of the spine in addition to providing structural and biological support. The current gold standard for graft materials is the autologous bone graft, which uses cancellous bone from the patient’s own hip (clinically termed the iliac crest bone graft or ICBG). ICBG produces the best results, but it must be extracted through an invasive procedure that is cumbersome for the surgeon and painful for the patient. There is currently no specialized device designed to extract sufficient volumes of ICBG for spinal surgery without high risk to the patient.

This team’s goal is to dramatically improve the procedure for extracting ICBG. The device will be minimally invasive, will standardize the harvesting procedure, and will allow for safe extraction of large volumes of ICBG. This will increase spinal fusion success rates while reducing patient morbidity, surgical time, and healthcare expenditures.

Antenatal Screening Kit: Improving Maternal Health Worldwide

Johns Hopkins University, 2010 - $16,000

Each year, nearly 600,000 women die worldwide as a result of complications arising from pregnancy and childbirth. In South Asia, barely 50% of women have access to antenatal care, and as a result millions of women over the years have died avoidable deaths.

This team is developing a kit consisting of rapid and cost-effective point-of-care tests to screen expectant mothers for various readily treatable diseases and health problems that can lead to complications during pregnancy. The kit contains different marker pens pre-filled with reagents and a special booklet. A simple mark on a piece of paper by the test pen creates a dipstick for urine, and results in an easily read color change, telling the healthcare worker if action is needed. The kit provides a 10 to 100 fold cost reduction in the cost of tests and longer shelf life for reagents in challenging environments.

The team is partnered with Jhpiego, a leading global NGO in maternal/child healthcare, which will provide access to test populations and marketing strategy development assistance.

Updates:

Antenatal Screening Kit profile

Antenatal Screening kit

Johns Hopkins University

Every second four babies are born across the world, totaling about 130 million births per year. Unfortunately, complications cause 6.3 million maternal and perinatal deaths per year, with the vast majority of those deaths occurring in developing countries—deaths that in many cases could have been prevented with basic interventions. But in some countries, up to half of expectant mothers do not have access to healthcare during their pregnancies.

This team of biomedical engineers is working closely with Jhpiego, the leading NGO in maternal and child healthcare, to develop an antenatal screening kit to deliver low-cost healthcare to women in even the remotest villages. The kit includes a variety of custom markers pre-filled with reagents for screening tests. The tests are intuitive and simple to use, allowing a semi-trained community health worker to mark a piece of paper and create a custom dipstick for the mother. The kit contains seven tests for conditions including pre-eclampsia, gestational diabetes, malnutrition, and anemia. The team is pilot testing the kit in Nepal.

back to complete list of Open Minds 2011 teams

Sustainable Medical Device Innovation for Developing Countries

Johns Hopkins University, 2010 - $41,500

This grant supports a new course, Sustainable Medical Device Innovation for Developing Countries, in Johns Hopkins’ Center for Bioengineering Innovation and Design (CBID). The course, being developed as a core requirement for a new one-year MS program at CBID, will have the explicit aim of training students in the process of identification, invention and implementation of healthcare technologies that solve clinical problems in developing countries.

Students will learn through immersive clinical experience, partnering with hospitals and community health centers in South Asia and Southern Africa. Over the course of two semesters, they will work in teams to invent and prototype multiple solutions to problems they identify, develop a clinical trial plan, identify manufacturing partners, and develop an appropriate business model. Once the projects reach a certain level of maturity, teams will receive intensive mentoring on how to pursue further funding opportunities to fully implement their ideas (Gates Foundation, USAID, etc.).

Master's Level Education in Bioengineering Innovation

Over the last four years, the Center of Bioengineering Innovation and Design (CBID, supported by an NCIIA Course and Program grant) within the Department of Biomedical Engineering at Johns Hopkins University has planned and launched a one-year master’s program focusing on the identification, creation and implementation of novel health care technologies.

This grant will fund prototype development costs for graduate student teams developing technologies in the CBID. Feedback from VCs and others emphasized the importance of developing very strong prototypes in order to increase the chances for securing funding and support. Faculty also plan to expand the program from twelve to fifteen students, and require teams to increase the number of and improve the quality of prototypes developed over the span of the program.

Updates:

Two biomedical device start-ups have spun out of the Master's Level Education in Bioengineering Innovation course:

Grant PI Bob Allen reports that so far 15 students have graduated from the program with MS degrees. JHPIEGO, JHU’s global health partner, is further developing two other projects from the grant: an electronic partogram and the antenatal screening kit (a 2010 E-Team grantee and Popular Science invention of the year).

Rapid Hypothermia Induction Device team (Johns Hopkins) wins BMEidea 2010

The winners of BMEidea 2010 were announced today, at the MD&M trade show in New York City. In first place, winning $10,000, is the Rapid Hypothermia Induction Device team from Johns Hopkins University.

Second place and $2,500 went to the Low-cost Ventilator (OneBreath) team from Stanford University. Third place and $1,000 went to the Natural Orifice Volume Enlargement (NOVEL) Device team from University of Cincinnati.

Read more about the finalists and see their prototypes here.

And read Medgadget.com's story on BMEidea 2010.

 

Cortical Concepts

Johns Hopkins University, 2009 - $20,000

The human spine is composed of vertically stacked vertebrae that form a protective canal for the spinal cord. Instability of the spine caused by vertebral fractures, deformities and other spinal disorders often requires surgical intervention, in which two metal screws are placed into parts of the vertebrae called pedicles and joined at adjacent vertebral levels with metal rods. However, patients with osteoporosis (and thus poor bone quality) are susceptible to screw pullout during the procedure. At the same time, osteoporotic patients stand to gain the most from the procedure.

Rather than reinvent the effective and well-established procedure of pedicle screw fixation, this E-Team is aiming to rebuild the strength of screw fixation in the pedicles by shifting the forces experienced by weak inner bone to strong outer bone. They call this method Corticoplasty™, and the device used in this approach will act as an intermediary between the bone-screw interface and provide a strong interference fit for existing screws in osteoporotic patients.

InSpiro

Johns Hopkins University, 2009 - $18,000

Every day as clinicians perform their morning rounds, patients are asked whether they have been using their incentive spirometer, an inexpensive bedside device that promotes deep breathing with a visual feedback mechanism. Current clinical protocol suggests performing deep breathing exercises using the incentive spirometers ten times per hour as a preventative measure to reduce postoperative pulmonary complications that include atelectasis, pneumonia, and bronchitis. As a testimony to their efficacy, incentive spirometers are provided to every single patient who undergoes general anesthesia. Unfortunately, it’s impossible to tell if a patient has actually been using the spirometer, forcing clinicians to rely on patient memory, which is neither objective nor accurate in the post-operative period.

This E-Team is designing an electronic, disposable incentive spirometer that will quantify when a patient uses it. The device is designed to allow hospital staff to monitor patient usage and lung capacity performance—features not possible with current embodiments. Ultimately, the team hopes to expand into the full spirometry market to help diagnose non-hospitalized patients for conditions such as pneumonia.

Johns Hopkins’s student design teams seal a licensing deal

 

For the past two years, The Center for Bioengineering Design, a Course and Program Grant-funded initiative at Johns Hopkins University, has provided bioengineering graduate students the tools and support to develop new medical devices.

One of the Center’s team design projects was recently given a licensing deal with Seguro Surgical, a Maryland company specializing in the commercialization of surgical instrumentation.

“SeguroSurgical’s…product line (the Lap-Pak) was borne out of one of our design team projects,” says instructor Robert Allen. The Lap-Pak is a device that cleanly and quickly repositions the bowel during a surgery.

Read more about the project. Read more about Seguro Surgical.

Improved Foot Sensor

Johns Hopkins University, 2001 - $8,200

Roughly 1.4 million lower extremity fractures, including 950,000 to the ankle, occur annually in the US. The majority of these musculoskeletal injuries require some type of physical therapy. Because the total cost involved in diagnosis, surgery, or rehabilitation of such injuries amounts to billions of dollars, this E-Team from John Hopkins University developed a low-cost foot sensor that aids patients in recovery.

Research shows that patients recover faster with limited weight-bearing programs, but gauging how much pressure to apply to the injury before doing harm is difficult. The team's foot sensor measured the pressure and alerted patients if they put too much pressure on their injury. Patients could adjust the pressure threshold according to the nature of the injury, the severity, and progress in rehabilitation.

The E-Team consisted of ten undergraduate students enrolled in a year-long biomedical engineering course sequence with skills in computer programming and computer, biomedical, and electrical engineering. The students worked under the umbrella of Homewood Biomedical Design Associates, a university-based corporation. An engineering professor worked with the team, along with an engineering lecturer, the clinical director of Physiotherapy Associates, and the president and founder of Venture Quest, Inc., a management firm.

Center for Bioengineering Innovation and Design

Johns Hopkins University, 2007 - $20,000

This grant further supports the programs that make up the new Center for Bioengineering Design and Innovation at Johns Hopkins. Specifically, the grant helps with the development of a non-thesis option for the Masters program that will allow students to take on a design project for two years, starting as a design team leader in year one. It's hoped that the non-thesis Masters track will produce four Masters students per year, with funding from industry, donations, and other grants.

Biocervical Technologies: Cutting Edge Technology for Pre-term Birth Detection

Johns Hopkins University, 2002 - $8,750

Over 400,000 premature births occur each year in the US, accounting for over $6 billion in annual health care spending. Statistics suggest that the number of premature births is rising, despite advances in prenatal care. Premature birth is associated with higher risk of maternal and infant death, and debilitating infant illnesses such as cerebral palsy, autism, mental retardation, and vision and hearing impairments. Currently, several tools on the market predict pre-term delivery, however the available diagnostic methods do not function early enough to safely and consistently administer labor-suppressing drugs.

This E-Team developed a cervical bioimpedance system that predicts the onset of birth early enough to safely administer preventative drugs. The system detects very subtle changes in cervical tissue composition, which indicate when the cervix is readying for childbirth. The system is composed of an electrode probe with a disposable sterile plastic tip containing the circuitry necessary to measure bioimpedance.

Update: the team has successfully licensed the technology (details not available).

Early Detection of Acute Renal Failure

Johns Hopkins University, 2004 - $12,000

This E-Team developed a new device designed for the early detection of acute renal failure (ARF). The device uses laser technology and Raman spectroscopy to provide data on metabolite excretion rates in near real-time (high levels of metabolite excretion are indicative of ARF). The device enables the detection of ARF in hospitalized patients up to 48 hours earlier than current detection methods. The detection of other biomarkers using this device is also possible, making the device useful in aiding with a number of clinical diagnoses.

ARF is seen in 5% of all hospitalized patients, and 4-15% of all patients who undergo cardiovascular surgery. It accounts for 30,000 deaths per year. Current detection methods are not effective in providing early detection of the disease, which is essential to effective treatment. By providing early detection capabilities, this device can give healthcare providers a jump start on effectively treating ARF.

EEG Keyboard

Johns Hopkins University, 2004 - $14,400

This E-Team developed the EEG Keyboard, a Brain-Computer Interface (BCI) typewriter system capable of translating electroencephalogram signals generated from electrical activity in the brain into characters on a screen. Electrodes are attached to the user's scalp, and he or she chooses characters either by focusing on a certain row or column in a flashing six-by-six matrix or by staring at a region of the screen flashing at a certain known frequency. Initially the product was targeted at the Locked-In Syndrome (LIS) community--individuals with paralysis of all voluntary muscles in the body, leaving them virtually unable to communicate.

The E-Team consisted of two professors of biomedical engineering (one of which won the 2003 BCI competition), eight biomedical engineering undergraduates, and three faculty advisors: one from neurology, one from biomedical engineering, and one from business.

Pull-Out Resistant Pedicle Screw for Osteoporotic Patients

Johns Hopkins University, 2006 - $18,500

Each year, approximately 550,000 osteoporotic patients in the US suffer from compression fractures that require pedicle screws in order to reconstruct the spine. These patients are currently given pain management treatments instead of pedicle screws, however, because osteoporotic bone isn't strong enough to hold the screws in, or prevent them from falling out. This E-Team plans to solve the problem by developing a pull-out resistant pedicle screw. The novel design, based on a vertebral compression fracture treatment known as kyphoplasty, consists of a two-part screw involving a hollow capture chamber and a threaded inner screw. The hollow chamber is inserted into the vertebral body, then the inner screw is brought through the chamber into a wet cement adhesive. As the cement cures, the stickiness of the screw is enhanced, providing greater pull-out resistance.

Dynamic Ankle-Foot Orthosis

Johns Hopkins University, 2006 - $15,126

People with ankle problems such as arthritis often wear supportive devices to help them walk. Traditionally ankle braces have been custom manufactured to meet specific patient needs, but in recent years there has been a movement toward prefabricated devices. While current prefabricated devices are capable of completely supporting the ankle, they often suffer from a lack of durability: the junction between the footplate and the upper support fails. Due to the high failure rates of existing products, physicians have voiced a need for a structurally sound and supportive ankle brace.

This E-Team is hoping to fill the need by designing a brace that incorporates the idea of recoil energy. The design includes a one-piece "sock" structure to allow for a greater fitting range, a resilient carbon-fiber foot-shin plate to provide the lever action that alleviates pressure at the ankle during walking, and stress distribution, particularly around the foot-plate strut joint that typically fails.

A Novel Hydrogel Microfiber for Small Diameter Vascular Grafts

Johns Hopkins University, 2006 - $19,900

Every year more than 500,000 coronary artery bypass surgeries are performed worldwide. While autografting (taking tissue from one part of the body and moving it to another) is the preferred technique, there are limitations: autografts cannot be obtained multiple times from one patient, and they fail when the patient lacks healthy blood vessels. Synthetic polymers are used in cases of weak blood vessels, but not when making small diameter vascular grafts (less than five mm) due to risks of stenosis (abnormal narrowing of a bodily canal or passageway), and thrombosis (a clot of coagulated blood attached at the site of formation in a blood vessel).

To fill the need for small diameter vascular grafts for people with weak blood vessels, this E-Team is developing the Hydrogel Microfiber, a hollow, polymeric cylinder in which living endothelial cells can be encapsulated. Concentric layers can be added to this fiber, each containing its own cell population. Once implanted in the patient, the cells in the fiber grow over time and eventually become fully integrated with the vessel wall.

Rotavirus Vaccination via Oral Thin Film Delivery

Johns Hopkins University, 2006 - $16,000

Rotavirus, a disease affecting children age five and younger, kills 600,000 people every year in the developing world. The virus infects the villi of the small intestines, leading to severe diarrhea, vomiting, high fever and dehydration. While rotavirus vaccines exist, they are currently delivered only in liquid form in a syringe, making the vaccine difficult to administer to infants and requiring expensive refrigeration to maintain. Building on thin film technology such as the popular Listerine Breath Strips, this E-Team is developing a method of delivering a rotavirus vaccine orally, on thin film. The team believes this design will have many advantages over current syringe-based methods, including simplifying storage and distribution due to the film's light weight and ability to be stored without refrigeration, and easier delivery to infants.

Above photo by Will Kirk.

Update:

Expandable Fusion Cage

Johns Hopkins University, 2007 - $17,000

Spinal fusion is a surgical procedure in which two or more vertebrae are fused together to relieve pain stemming from degenerative disc disease, spinal fractures, and other sources of back pain. The preferred surgical method is Transforaminal Lumbar Interbody Fusion (TLIF), where the disc is removed through an incision over the lumbar spine and a structural titanium cage and bone graft are inserted in its place. While this approach is less invasive than others and leads to lower trauma and complication rates, the small space in which to work and the vulnerability of local nerves make the surgery time-consuming and difficult to perform. Further, traditional cages have fixed dimensions and must be coaxed into the spine, possibly causing nerve damage.

This E-Team is developing a new approach to the procedure with an expandable fusion cage. The flexible titanium cage will be compressed during insertion and expanded during the positioning phase of the procedure. When the device is fit into the spine, a balloon will be inflated, expanding the cage to the exact size necessary and filling in all available space.

Ultrasound-Guided Noninvasive Measurement of Central Venous Pressure

Johns Hopkins University, 2007 - $12,220

Central Venous Pressure (CVP) is the pressure of blood in the thoracic vena cava, near the right atrium of the heart. CVP reflects the amount of blood returning to the heart and the ability of the heart to pump the blood into the arterial system, and is a key parameter used in diagnosing serious conditions like heart failure and monitoring patient fluid levels. Currently the only method of accurately measuring CVP involves surgically inserting a catheter through a major vein, which is costly, highly invasive, and can lead to complications. For these reasons, CVP measurements are usually only taken for critical patients, even though early detection could help treat conditions like congestive heart failure.

This E-Team is developing a small handheld device, called cVein, that provides a noninvasive and accurate method of measuring CVP. Using an ultrasound machine to visualize the internal jugular (IJ) vein, the operator applies pressure to the vein with cVein. The device records the pressure required to collapse the IJ and displays the reading to the operator. This quick and noninvasive measurement method could be used in emergency or primary care settings, allowing for earlier diagnosis of problems.

Portable Negative Pressure Ventilation Device

Johns Hopkins University, 2008 - $17,562

Negative Pressure Ventilation (NPV) is the mechanism by which bodies breath naturally; air passively flows into the lungs due to the negative pressure of the diaphragm movement. This team's idea is to address the problem of increased mortality due to the detrimental effects of Positive Pressure Ventilation (PPV), when paramedics manually force air into the lungs using a bag valve mask. PPV can lead to longer hospital discharge times.

The team developed a prototype that electronically stimulates the phrenic nerve in the neck, forcing the diaphragm to take in air. Their prototype includes a neck electrode patch to deliver pulses to the phrenic nerve, a feedback system to determine if the patient is breathing, a stimulation unit that is battery powered and rechargeable, and software for a tablet PC to control the stimulation and the breathing rate.

Dizziness Diagnostic Device (D3)

Johns Hopkins University, 2008 - $17,000

This E-Team is developing a motorized head-moving device that effectively diagnoses dizziness. Dizziness is the number one medical complaint among the elderly and the third most frequent complaint that brings people to primary care and emergency rooms. Dizziness often leads to falls, which can be fatal or cause serious bodily injury, and result in billions of dollars in health care fees. While many causes of dizziness are treatable, current diagnostic techniques are complicated, costly, and uncomfortable for patients.

The team's device, D3, is simple, user-friendly, and reliable. The patient wears a helmet and places a "bite bar" in their mouth that has been molded to their dentition. A video camera monitors eye rotation responses while head is rotated.

The Negative X-ray Rapid System

Johns Hopkins University, 2008 - $16,500

The Negative X-ray Rapid System is a device that utilizes software to detect retained foreign bodies (RFBs) in post-surgical x-rays. RFBs--surgical instruments left inside the patient's body after surgery--can cause medical complications, result in death in up to 35% of cases, and almost always require a second operation to remove the forgotten item. Right now, the process of obtaining and analyzing post-surgical x-rays is laborious and expensive. The Negative X-ray Rapid System will dramatically reduce the resources needed to obtain a negative x-ray without compromising accuracy.

Development of a Total Cancer Marker through Single Molecule Assessment of DNA Integrity

Johns Hopkins University, 2008 - $20,000

Despite a number of advances in cancer detection technologies, the development of clinically validated, blood-based cancer biomarkers remains an unmet challenge for many common cancers. Better markers would lead to earlier detection, saving lives and cutting down on hospital costs. A new method, the DNA Integrity Assay (DIA) has the potential to accurately discriminate cancerous cells from normal cells for a wide range of cancers, but its clinical acceptance has been limited due to the complexity of the test, sampling errors, and the high cost of the materials, instruments and highly trained personnel needed to run it.

This E-Team is developing a new DIA testing method called smDIA (single molecule assessment of DNA integrity), which has the potential to eliminate errors and reduce the costs associated with the traditional DIA approach. In this method, a patient’s DNA sample (blood, stool, etc.) is transported by a microfluidic device through a sheet of laser beams (Cylindrical Illumination Confocal Spectroscopy), enabling direct analysis of the patient's DNA integrity in a rapid, uniform manner.

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