The 16th annual “Create the Future” Design Contest for engineers, students, and entrepreneurs worldwide, sponsored by COMSOL, Inc., and Mouser Electronics, drew many innovative product ideas from engineers and students in 60 countries. The Medical category itself received 62 outstanding entries from 18 countries. Analog Devices and Intel were supporting sponsors, and Zeus sponsored the Medical category. The contest, which was established in 2002, recognizes and rewards engineering innovations that benefit humanity, the environment, and the economy.
Winners were selected in late September from the seven categories: Medical Products, Consumer Products, Electronics, Machinery/Automation/Robotics, Sustainable Technologies, Automotive/Transportation, and Aerospace & Defense. In addition to product ideas at the concept or prototype stage, contestants could submit designs for commercial products introduced to the market within the last 12 months.
The grand prize winner receives $20,000, while the first-place winner in each category receives a Hewlett-Packard deskside workstation computer or laptop. The Top Ten Most Popular Entries, as voted on by contest site visitors, will each receive an award-winning magnet infused product including Magnet Kit, GYRO Duo, and Nanodots Magnetic Constructors.
In addition to the winners and honorable mentions described in this article, the grand prize entry, which won in the in the Consumer Products category also has medical applications. Brookhaven National Laboratory's Center for Functional Nanomaterials (CFN) has developed a method for creating surface nanotextures that effectively eliminates optical reflections from glass, silicon, and plastics. The Invisible Glass can provide an alternative to the damage-prone antireflective coatings conventionally used in lasers that emit powerful pulses of light, such as those applied to manufacture medical devices.
This article introduces the Medical Category winner as well as the four Medical Category Honorable Mentions. The top prize winners will be honored at an awards reception in New York City this month. Congratulations to all who entered. All of the entries can be seen here .
Medical Category Winner
Implantable Sensor Technology Platform for Advanced Prosthetic Control
Alanie Atyabi, Brian Dearden, Dave Brown, Dave Melbye, Dianna Han, Ed Hillery, Emil Istoc, Greg Golamirians, Harshit Suri, Jaime Gutierrez, Joseph Calderon, Justin Loo, Mike Perrin, Patrick Nercessian, Sam Bowman, Sam Yang, Taunyia Woolfolk, Valma Klein, and Yesenia Acevedo The Alfred Mann Foundation, Valencia, CA
The Implantable Myoelectric Sensor (IMES) system is an implantable sensor technology platform capable of transmitting localized myoelectric signals simultaneously from multiple muscle sources. It is intended to be integrated into prosthetic systems to control electromechanical prosthetic devices. The IMES implants detect myoelectric signals generated by residual muscles of an amputated limb, which are still under control of the brain. These signals are wirelessly transmitted to an external processor that controls the movement of a prosthetic device. Control can be intuitive by assigning the muscle's signal to a prosthetic function that correlates with the hand function that muscle provided prior to its amputation.
Currently available myoelectric prostheses use these same signals, but they are detected from the surface of the skin, which results in poor specificity, repeatability and reliability due to crosstalk, electrode liftoff, and sweat. Current systems can typically only pick up one or two signals. The patient has to use these same signals to control a variety of different movements, which can only be activated one at a time. The user has to signal a mode change to switch between the different functions. This kind of sequential control is slow and non-intuitive. These limitations are addressed by the IMES system using permanently implanted sensors to detect signals from within the muscles.
For the IMES, tiny implants consist of custom electronics housed in hermetically sealed, biocompatible ceramic capsules with metal endcaps. Each one is only 16 mm long and 2.5 mm in diameter. The IMES are inductively powered through a magnetic field produced by a coil laminated inside the wall of a prosthetic socket frame. Bidirectional telemetry is achieved through modulation of this field. Each implant amplifies, filters, and transmits the detected signal to a telemetry controller (TC).
In the first-generation product, which was clinically demonstrated in patients with transradial, transhumeral, transtibial, and transfemoral amputation, the TC was incorporated into a belt pack connected to the coil by a cable, but improvements have since been made that allow for integration of the TC in the prosthetic frame housing. The TC separates out the samples from each of the implants, reconstructs them into an analog envelope, and then routs each one to a pre-assigned motor of the prosthesis to effect a particular movement. The different movements can all occur simultaneously. In the second-generation product, raw digital samples of signals acquired from up to 16 devices can be fed to a controller that uses machine learning to determine which muscles have contracted and either activate different hand grasps or perform individual finger control of a robotic hand.
At present, the limitation of advanced myoelectric prostheses is not their ability to reproduce near-normal human movements, but rather the lack of an effective means to control the multitude of actions they are capable of. IMES implanted into residual musculature address the core issue of how to extract multichannel biological signals that are stable and reliable over long periods of time.
Stretchable Electronics for Stroke Recovery
Stroke survivors might suffer from different symptoms such as aphasia — loss of ability to understand or express speech — and dysphagia — difficulty or discomfort in swallowing. Proper therapies can alleviate these symptoms. Tracking the patients’ improvement in an accurate and continuous manner would provide important feedback for therapeutic development. Currently, clinicians use voice recorders to measure the patient's speech quality and large desktop instruments to monitor the patient's swallowing ability.
However, these techniques have multiple limitations. For the voice recorder, the quality and accuracy of the measurement can be easily affected by ambient noise of the measuring environment. Identifying the specific subject's speech requires expensive labors and computations. The desktop instruments for swallowing measurements are cumbersome and not portable. They also restrain the testing circumstances because large movement of the patient can result in unreliable data collection.
This device, featuring the stretchable sensor, offers a solution to these problems. First, with its flexible mechanical form factor, the device conformally mounts onto the patient and records clean and accurate data. Taking advantages of the mechanical structural design of 3D buckled serpentine interconnects, the device can stretch 200 percent without failure.
When mounted to the neck, which bridges the circulatory system and respiratory system between the head and torso, a single device can acquire heart rate, respiration rate, talking time, and swallowing quality simultaneously. The device is shaped anatomically, matching with the suprasternal notch (the notch between the collar bones), so that the patients can place the device on the proper mounting location without a clinician's presence.
The device is mechanically well coupled to the skin and measures small skin vibration or large core-body movement but not any airborne acoustic wave from the ambience. Hence, unlike the microphone, which records audible sounds indistinguishably, the device only records the patient's physical activity and is isolated from any disturbance from the environmental noise.
In addition, the device has wireless charging and data transmission functionalities. The electronics are completely encapsulated by the elastomeric membrane to be waterproof. The device utilizes double-sided adhesives as an mounting interface between the device and the skin which can be replaced after each use. The device is truly reusable for daily measurements.
With these features and functionalities, the device provides more accurate and unprecedented metrics for the clinicians to understand the stroke survivors’ recovery state and allows them to monitor the patients continuously far beyond the intermittent examinations within clinics.
SurgiBox: The Operating Room in a Backpack
Problem. Worldwide, an estimated 18 million people die annually due to lack of or inadequate safe surgical care. Yet in austere settings, providing safe surgery is challenging: 1) nonsterile facilities result in high patient infection rates of 15 percent and above, 2) bodily fluid splashes breach the limited personal protective equipment to infect surgical providers, with the chronic epidemic of 85,000 annual provider infections, highlighted by the Ebola crisis, and 3) surgical capacity relies on burdensome supply chains while teams must be as agile as possible.
The old paradigm of safe surgery was to protect entire rooms, which inspired bulky operating facilities in buildings, tents, trailers, trucks, and semiportable ventilation systems, which all are hard to transport to austere settings, expensive to run and maintain, and rely on electrical grids or large generators.
Solution. SurgiBox shrinks the sterility problem for surgery down from the size of the operating room to the size of the patient. SurgiBox offers excellent protection of patients against surgical site infections and simultaneously offers protection of providers by forming a barrier against splashes of patient's bodily fluids, while it is ultra-portable, rapidly deployable, low cost, requires minimal maintenance, and of minimal environmental footprint.
Design. SurgiBox consists of a clear sterile drape with antimicrobial adhesive, cut-through bottom. The drape is inflated into a bubble over the incision site with air processed through the battery-powered environmental control system. Providers operate through arm ports and materials move in and out via material ports. The system is optimized and tested for the most common surgical and OB/GYN procedures and is designed to be easily incorporated into existing workflows. It will be distributed as fully self-contained, ready-to-use kits suitable for limited spaces, such as backpacks.
SurgiBox is a three-part product, leveraging well-established manufacturing norms but incorporating some cutting-edge innovations. The patient-contacting enclosure is manufactured in much the same way as and with comparable production costs to other surgical gowns and drapes. The environmental control system is manufactured as a filter cartridge-blower assembly that connects via tubing to the enclosure. Modified off-the-shelf batteries are included that can be charged via almost any local source, from car batteries to laptops to outlets. Production cost for the reusable portion is orders of magnitude lower than for operating room ventilation systems, whether full-size or semi-portable ones. The developers expect that the device will be able to be manufactured to consistently high quality to comply with US FDA General Controls and similar regulations.
Market. It is expected to see first use in military, humanitarian, and disaster-relief settings, where the company is already actively engaging with defense and nongovernmental entities. The centralization of medical consumable stockpiles helps to make this a feasible early market worth millions of dollars. From there, SurgiBox will help to increase safety of ambulatory as well as complex procedures in high- and middle-income countries. Ultimately, with effective enough economy of scale and widespread enough acceptance, SurgiBox will reach anywhere safe surgery is needed.
A Smart Point of Care Human Blood Analysis Device
Sandia National Labs has developed a new medical diagnostic tool called SpinDx. The SpinDx was developed for conducting simultaneous multiplexed immunoassays and white blood cell counts in less than 15 minutes. The technique is based on centrifugal microfluidics, or lab-on-a-disk technology, which uses centrifugal forces to manipulate samples and reagents through microfluidic channels on the disk. The device can determine a patient's white blood cell count, analyze important protein markers, and process up to 64 assays from a single sample in a matter of minutes.
To obtain blood cell counts, blood samples are mixed on the disk with labeling agents to label leukocytes prior to the centrifugation. The cells then separate along a preloaded density media based on their size and their density differences. The integrated fluorescent signal of each cell band is used to quantify individual cell population counts. The research applies the Sandia Lab-on-a-Disk technology to develop a smart microfluidic point-of-care device for human blood testing. The device performs blood analysis at the point of care and results are available in minutes rather than days. It performs 64 assays on a single disk. The company is continuing to work with its partner Sandia Labs.
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Braiding Technology Based Stent Concept for Endoluminal Usage in Coronary Bifurcations
For many years, cardiovascular diseases have been the number one cause of death in Germany. To reopen the morbid narrowed coronary vessels for a sufficient blood circulation, an interventional treatment is possible. In this case, the vessel gets expanded and is additionally supported by an endoluminal vascular implant, a so-called stent. Coronary stents are commercially available in many different types and are already successfully used, but in the case of a stenosis in a bifurcated coronary region, the otherwise uncomplicated and safe treatment still causes some problems.
The commercially available stents for coronary bifurcations are usually laser cut two-stent systems. In this case, a first stent is placed and expanded in the main vessel, and in a second step, manually cracked in the position of the side vessel. Through the generated hole, a second stent can be placed and inflated. With this procedure, the critical region is the cross section, in which the two stents are not securely connected, to guarantee a plaque shift-free and fully covered and supported transition area. Additionally, the flexibility of laser cut systems is limited.
The aim of this new invention is to generate a product that is on one hand as flexible and compressible as possible, and on the other hand, ensures a proper dilation and support of the main and side vessel. To realize extreme compressibility and flexibility, a newly invented variation braiding technology has been chosen. With this technique, it is able to write a program to produce a customized bifurcated y-shaped braid in one single fully automated braiding step.
The material selected was a shape memory alloy nickel/titanium, which, in combination with the braiding technology, is able to generate the desired flexibility and, at the same time, enables the stent to radially expand independently when placed in the correct position in the vessel.
To create the door to the side vessel, one of the manufactured arms is shortened, and similar to a bud, pulled into the other arm. Following, the stent is compressed and implanted into the constricted area in the vessel. There the stent expands and opens the main vessel. Finally, the pulled-in side arm gets released to open and support the crossover to the side vessel. To support the side vessel, a second simple tube stent gets implanted through the “opened and secured door.”
Compared with commonly used stent systems, the stent is more flexible and has a higher level of compressibility. As soon as the compressed stent has been placed in the right position, the door opener can be released so that it deploys into the side vessel independently and dilates the critical crossover without plaque shift. If necessary, a second stent can be placed in the side vessel. The crossover is securely covered, and injuries and restenosis can be avoided. To avoid injuries, all wire ends need to be secured. First prototypes have been produced.
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