Nanobiomimetic reagent-free sensing and energy storage
The handheld Pioneering I device comprised of ABS’s nanobiomimetic sensor array technology coupled with Groundswell’s platform technology in 4D contour mapping. The mapping output reflects the cancer communication with the sensor membrane causing energy change, heat change, membrane potential change and spatiotemporal sensory-energy image change without using antibody tracer, and no labeling, hence the results are magnitude sensitive for detecting a single cancer in real time and image based on the quantitation of cancer cells measured in human blood and in vivo healthy breast tissue. The energy-sensory image obtained using patient blood can identify when and where the cancer cells, or proteins initiate the pathological change in 3D location. The device provides a first in class diagnostic alternative to biopsy testing that will bring great benefits to patients, the society and market potential. Pioneering II is a handhold 4D cancer healing device used to apply spontaneous electric pulse at the top skin of the breast to heal the cancer. Our in vitro data demonstrated it is capable to heal cancer. Orders of magnitudes lower current and short time compared with market devices. Hence our device brings safety and healing benefits.
3D Optical Machine Vision Platform
Our system can capture and maintain a 3D model on human tissue with <100 micron accuracy, in real time, during surgery. Any other scanner would capture a blur. In addition, our system can simultaneously analyze tissue, differentiating between bone, tumors, brain tissue (grey or white matter), etc. This allows surgeons to take all of the unhealthy tissue, while preserving the most healthy tissue possible. This will prevent the need for costly and risk additive intra-operative MRI's, making brain surgery faster and more accurate, preventing deaths and lifelong disabilities for patients. Hospitals will save billions in costs associated with failed, aborted, or prolonged procedures. This clinically accurate product can be used to guide surgical robots, or could be used on a drone to scan terrain.
Method for Manufacturing a Biosensor Strip Using Paper Advantageous for Mass Production and a Structure Thereof
(The Present Invention) Purpose: A method for manufacturing a biosensor strip using paper and a structure thereof are provided to produce the biosensor strip at low costs and to reduce environmental pollution. Simple Manufacturing Method with Paper: A biosensor strip is manufactured using paper with electrode patterns printed on a lower plate of paper material through screen-printing/carbon-ink-printing process using an inkjet printer. Adhesive film is formed in a portion of top of lower plate except for a portion where a channel for inserting a biomaterial sample is formed. When inserting the biomaterial sample through an inlet of the channel, an upper plate of the paper material where an air outlet for discharging air is formed correspondingly on the top of the channel is adhered to the adhesive film. Humidity Sensor for Reducing Errors due to Humidity: The biosensor further includes a humidity sensor to detect the capacitance changes due to humidity in environment and humidity between the electrode patterns. Based on the detected humidity and prediction of the influence of the humidity on the capacitance, the biosensor can reduce the errors caused by humidity changes.
The Internet of Medical Things
The UsWB technology will be transitioned into an implantable Internet of Medical Things device that will be employed in a multitude of therapies in the human and veterinary markets. The device will consist of a recon gurable, miniaturized embedded system with a software-de ned ultrasonic transceiver that implements in low-power hardware the UsWB ultrasonic networking capabilities. The societal impacts of the proposed technology are as broad and deep as the applications of networked medical implants. Patients will bene fit from implants that provide real-time wireless telemetry and reprogrammability while minimally affecting the implant battery life. According to recent studies, 9% of patients experienced complications following a cardiac battery replacement. Longer battery life would reduce these risks, as well as replacement costs ($37k per replacement, with up to 4-5 replacements in a lifetime). BioNet Sonar's technology will also enable the development of advanced devices and therapies that require multiple sensing and stimulating devices deployed inside the body, a task which is today largely unfeasible. Existing, as well as futuristic applications of wireless technology to medical implantable (including wearable) devices, will grow into a new market segment that several analysts are already starting to refer to as "The Internet of Medical Things".
Currently available treatment options for heart failure following acute myocardial infarction have a number of disadvantages, which prevent the success of these treatments in improving patient outcomes. Cell-based approaches were studied for several years, without successful regeneration of cardiac tissue. Tissue engineered cardiac patches have limited efficacy and manufacturability, and synthetic materials often result in an inflammatory response and thrombosis. To overcome these issues, ECMedical is developing a next-generation cardiac patch that would maintain high mechanical strength, while also promoting cardiac tissue regeneration. This proposed product combines aspects of tissue engineering, biomaterial science, and medical product development to implement this approach.
Artificial Meniscus Implant
Background: Meniscal tears are one of the most common injuries of the knee; around 850,000 meniscal injury related surgeries occur annually in the US. Traumatic tears in the meniscus (the thin fibrous cartilage between the surfaces of some joints) occur from sharp movements and usually occur in younger people. A torn meniscus can cause pain, swelling in the joint, impaired movement, and can eventually lead to osteoarthritis, a degenerative joint disease. A meniscal tear can be treated by partial or total removal of the meniscus, which is replaced with an implant. Unfortunately, these implants can lead to decreased space between the joints, osteoarthritis, and may need to be replaced. Georgia Tech inventors have created an artificial meniscus implant that can be fixed in the joint to hold the implant in place. The implant is made of a composite material. Extensions from the meniscus to allow for fixation in the joint. The implant withstands compressive loads in similar ways as the natural meniscus fibers and the fixation help to keep the implant aligned correctly. This implant is able to mimic the mechanical properties of the natural meniscus and is resistant to wear.
IV Infiltration Detection using Non-Invasive Sensors
Background: IV infiltration is a common problem, where fluid enters surrounding tissue rather than the vein as intended. Infiltration occurs from issues such as solution tissue toxicity, vasoconstrictors, infusion pressure, and mechanically puncturing the lining of the vein. IV infiltration can result in medical emergencies, with the most critical aspect is timely detection. Currently infiltration is primarily detected by witnessing symptoms or by patients alerting medical staff. A detection system is needed when patients cannot notify medical staff of the symptoms, for example when under anesthesia or undergoing surgery. Early infiltration detection would also benefit neonatal and pediatric units, where complications are most severe and timely responses are of great necessity. Technology:Georgia Tech inventors have developed a system and method for detecting IV infiltration. The non-invasive sensing modalities monitor for two responses that occur during infiltration: stretching of skin around the infiltration site, and the reduction in bioimpedance. In addition, the technology includes an algorithm for detecting the change of the patient’s physiology and an alert to medical staff. The incorporation of multiple modalities ensures both early detection and accurate identification for quick response time and treatment.
Point-of-care testing (POCT) is highly required for enhanced patient outcomes with early/rapid diagnosis in an emergency situation or patient monitoring. Conventional lateral flow immunoassay (LFIA) sensors are not sometimes suitable for early diagnosis because of its low detection sensitivity. This technology enables highly sensitive detection (pg/mL level) of target biomarkers in 20 min. Based on the LFIA combined with a swellable polymer, the developed immunosensor shows an automated signal amplification after immunoassay and easy-to-use with a minimum user operation. It is suitable for rapid diagnosis in acute myocardial infarction (AMI) which requires POCT-based high-sensitivity detection of troponin I lower than 1 pg/mL.
Lab-on-paper technology for point-of-care and all-in-one molecular diagnosis
User friendly molecular diagnosis with point-of-care (POCT) testing is important for improving survival rate of patients with infectious diseases or suppressing epidemic spreading. However, it is strictly limited to perform POCT with current real-time PCR-based molecular diagnostics methods. We developed a hand-held nucleic acid separation device (Biomedical Physics & Engineering Express, in press) and isothermal molecular diagnosis devices (Analytical chemistry 90, 10211; Theranostics 7, 2220) based on a lab-on-paper technology. Now we are connecting the nucleic acid separation and the isothermal amplification devices without any instrumental assistance. The all-in-one molecular diagnostic kit in which filtration, rupturing, nucleic acid collection, isothermal amplification, and measurement can be performed automatically within 60 min with a miniaturized fluorescent detector.
Rapid Point-of-Need DNA Detection
While there are many laboratory tests for gastrointestinal GI pathogens that cause diarrheal diseases such as the Biofire instruments, currently, there is no test like our test which is portable, rapid (15 minutes compared to Biofire 1 hour), low cost (made of paper) and does not require electric power. Our test can be used by healthcare providers to to diagnose and treat their patients in real time. The prescription of antibiotics after a real time confirmation with a diagnostic can increase antibiotic stewardship and reduce the emergence and spread of antibiotic resistance in society. Our technology would be disruptive in the healthcare industry because it will save money being used for expensive laboratory tests (eg Biofire FilmArray costs $1200 per test) that require shipping of samples, laboratory overhead costs and personnel training costs. It can replace the many GI pathogen lab tests in the market especially in case where labs are far from the market.
Device for assessing the state of healing of long bones
The state of healing of internally fixated long bones is traditionally assessed using X-ray technology. However, using X-ray technology exposes patients to radiation and surgeons have to make an assessment based on imagery, which is subjective. This invention is a wearable device, which assesses the state of healing of long bones using vibrational analysis. The stiffness of a fractured bone is lower compared to healthy bones and its vibrational response is therefore different. However, due to soft tissue and the fixation device itself, vibrational healing analysis is challenging. This invention is a wearable device that is strapped around the fractured limb; the device contains two sensors and a strike point. The two sensors allow to separate the torsional from the bending mode; the latter can then be mapped onto a healing index, which allows to track the healing progress over time.
A wearable, disposable, light emitting photomedical treatment device
Photodynamic therapy (PDT) and photobiomodulation therapy (PBMT) have been demonstrated as minimally invasive or noninvasive strategies to treat cancers and infections, stimulate wound repair, reduce pain, promote hair growth, etc. Widespread clinical adoption has been hindered by current equipment based on lasers or light emitting diode (LED) arrays which are expensive, heavy, and rigid; in addition, expensive in-office visits are usually required for treatments. QLEDCures’ patent-pending technology is based on record breaking ultrabright quantum dot light emitting diodes (QLEDs) that can work as thin, light weight and large area wearable light emitting bandage-type products for use in PDT or PBMT, such that patients can receive treatment while doing daily tasks with minimal interruption. In addition, the inherent tunability of the quantum dots means our QLEDs can be customized for specific medical conditions. The technology has been proven effective in preliminary in-vitro PBMT and PDT studies carried out by leading photomedicine experts and holds promise to enable widespread clinical adoption of PDT and PBMT to transform healthcare industry in managing cancer, acute and chronic wounds, inflammation, combat antibiotic-resistant bacteria, aesthetic medicine, etc. The total addressable market is on the order of tens of billions of dollars.
Point-of-care sensors for diagnosing bacterial infections
By providing immediate identification of all of the most common bacterial pathogens, QSM technology will change the management paradigm for treatment of infectious diseases with antibiotics. Our sensing approach utilizes proprietary aptamers developed against unique quorum sensing molecules (QSM) and virulence factors secreted by bacterial pathogens that identify the particular species that is present in infected bodily fluids. These target molecules are present in significantly greater quantities in specimens than the pathogenic cells, allowing immediate detection by our sensors. We have uniquely combined the selectivity and specificity provided by aptamers with an electrochemical sensing approach that allows quantitative measurement of the target molecule concentrations in any bodily fluid without sample preparation or external controls. Since aptamers can be generated for any biomarker, our electrochemical aptamer-based detection platform can be extended to other infections and diseases. The platform can also be integrated with medical devices to monitor chronically ill, at-risk patients for the presence of bacteria, prior to the start of symptoms associated with infection. Our timely diagnosis will allow directed treatment, reducing medical complications arising from infections and decreasing healthcare costs.
Bringing AI into Neuro-Oncology - Tumor Surviellance
In current clinical practice, radiation oncologists manually perform pixel-by-pixel delineation of tumor boundaries to define the target for radiation treatment. Subsequently, dosimetrists mark boundaries of healthy organs to ensure that critical brain structures are not irradiated. There are no current automatic tumor boundary delineation solutions available in oncology clinics. What is our solution? We will develop an AI-based adaptive, end-to-end solution to delineate (or segment) tumor boundaries in MRI/CT scans. The segmentation results will be used for radiation therapy through integration with treatment planning systems. The same boundary markings will also be used to calculate tumor volume and assist physicians in tumor surveillance, estimation of tumor progression over time, and prediction of tumor growth in the future. Why our solution? Automatic, accurate, and timely segmentation of tumor boundaries would transform radiation therapy by reducing treatment planning time from hours to a few minutes. Our tumor surveillance solution can detect tumor growth more than three years earlier than detection by board-certified radiologists. Our preliminary results for both tumor boundary delineation and surveillance strongly support our claims. Our solution will integrate seamlessly with existing clinical systems including picture archiving and communication system (PACS) and radiation treatment planning systems.
Highly sticky adhesive for cornea repair
We at the Department of Chemical Engineering at Rowan University have developed a modified hydrogel to make antimicrobial, highly adhesive for surgical applications. This is a material platform to make cost-effective, sutureless, and user-friendly adhesives to heal injury to biological tissue and save operative and post-operative time and cost. The current primary needs for ocular trauma surgery entail operative and postoperative time and cost reduction. Currently, there are no such FDA approved material platforms to effectively replace the presently used techniques of suturing. The merit of this novel material platform is that it is an antibacterial and hemostatic bioadhesive based on a bio ionic liquid functionalized biopolymer. We expect biocompatibility, biodegradability, no toxicity, and excellent adhesion to tissues even in the presence of body fluids. We also expect this material platform to aid in blood coagulation, facilitate healing and inhibit bacterial growth. This innovation will circumvent the limitations of current surgical approaches as well as post-operative care and cost in corneal repair and in the future can be extended to repair of other human tissues.
New Nasal Delivery System improves Olfactory Targeting with Electrostatic Control
This device is designed specifically for olfactory delivery for the treatment of neurological disorders, such as Holoprosencephaly in infants, Cerebral Palsy in children, and Alzheimer’s diseases in senior populations. Merits of the new device include: 1. Electric guided drug particles can be contact-free from the airway walls, which significantly reduces the drug loss and increases the olfactory dosage. 2. The proposed delivery device has the potential of alleviating or overcoming the nose-to-brain bottleneck posed by extremely low olfactory deposition. 3. Delivery does not rely on inhalation maneuvers, making it suitable for seniors or patients with respiratory distresses. 4. Electric guided drug particles can be free of ferric magnetic materials, therefore minimizing side effects from metallic accumulations. 5. The proposed platform can be easily adapted for target drug delivery at respiratory sites other than the olfactory region by modifying electrode layouts and voltage input frequencies. The delivery system has two components. The first is a head-mounted nasal mask that houses the electrodes and helps to fix the position of the electrodes relative to the patient head. The second part is a particle-generation-charging device that comprises a jet nebulizer, a charging ring, a reserve, and a point-release nozzle.
Rapid method to improve cardiovascular disease diagnosis
The technology describes a diagnostic tool for cardiovascular disease (CVD) which combines imaging and computational modelling to derive coronary physiological indices for improved clinical decision making without the need for invasive wires. The tool is a rapid evaluation system which enhances CVD diagnosis and enable individualized clinical decision making. The system combines proprietary computational process with data obtained from angiography and intravascular optical coherence tomography to provide physiological information – including the location and size of heart damage, the coronary artery’s fractional flow reserve (FFR) and endothelial shear stress – in more detail than existing methods. Processing can be executed on a personal computer within minutes. In addition, the physiological information can be overlaid on 3D graphical representations of the coronary vessel in question, which can then be incorporated into existing diagnostic tools, allowing for more holistic interpretation by clinicians. Proof-of-concept using patient data has demonstrated the method’s validity. A comparison of the method to standard tools for measuring FFR, which require the use of invasive physical wires, found no difference in sensitivity.
Non-Contact Heart Rate and Respiration Monitoring
The developed millimeter-wave (mmW) micro-Radar is able to continuously monitor heart rate and respiration rate simultaneously in a non-contact manner. The solution consists of two core inventions: the mmW self-isolated harmonic active radiator and the fundamental-and-harmonic dual-frequency Doppler radar system. The technology consists of both hardware and software. In its final form, the product will be a desktop or handheld device that can be used for non-contact/through-wall heart rate and respiration monitoring from static human objects from a distance in the range of a few centimeters to a few meters. The non-contact remote monitoring provides comfort and convenience for users, while also minimizing interferences with the user’s natural status. This technology has also robust signal accuracy even in the presence of device movement. The system components are contained in a small 1.5 mm 1.5 mm chip, which facilitates the integration of this technology into other devices. At present, many technologies have been developed for non-invasive and continuous monitoring of heart rate and respiration, but most of them (ECG, impedance, piezo-electric, and PPG) still require close contact to the human skin, while some of them (PPG and camera) are susceptible to the ambient lighting conditions
Gold-Silver Alloy Nanoprobes for Clinical Immunolabeling
ANPs strongly scatter light, such that quantification is then a simple matter of particle counting and can be automated through image analysis software. Furthermore, it is possible to control the color of the ANPs by controlling their composition. Thus, ANPs with different colors can target different markers simultaneously for multiplexed detection. ANPs offer a stable signal because they do not suffer from photobleaching. Moreover, the strong optical allows direct immunolabeling without the need for secondary antibodies such that the preparation time is significantly reduced and multiplexing should be free from cross-reactivity. The target application is immunolabeling of biopsy tissues for cancer diagnosis and personalized treatment selection. Different markers (proliferation markers, hormone markers...) have already been identified in correlation with specific treatments for number of high incidence cancers such as breast cancer and lung cancer.
Eggshell particle reinforced biomaterials for biomedical applications
Eggshell particles are typically evaluated as animal waste and discarded. However, inventor has found unique applications of chicken eggshells when combined with hydrogel-based materials and used them in fabrication of new biomaterials. Inventor has developed a new class of hydrogels using chicken eggshell particles: - Made from micron-sized crushed eggshell particles combined with hydrogels. - Designed for use in many applications of tissue regenerative use, including where current methods fall short. - Synthesized using photo-crosslinking with UV light to create a homogeneous solution. These hydrogels have outstanding tunability in physical, chemical, and biological properties, and have significantly improved properties for biomedical applications. These biomaterials support tissue formation and regeneration and are suitable for biomedical applications related to mineralized tissues such as bone, cartilage, tooth, and tendon. Re-using animal waste, inventors have created unique and valuable biomaterials for tissue regeneration and are able to address some of the major limitations of the existing biomaterials.
Fiber-Optic Based Pressure Sensor
The UML invention enables an optical fiber pressure sensor to meet medical requirements. The invention has developed the process to directly bond a thin silica diaphragm to the end of an optical fiber under high temperature with no epoxy involved. A silica diaphragm can be thermally oxidized with strict control from 0.1 μm to 10 μm. The cavity can be fabricated by chemical etching. Bonding can be achieved by laser bonding, electrical discharge fusion bonding, flame fusion bonding, etc. The fabrication can be optimized on the MEMS fabricated chip for a cost-effective batch process. Applications Medical Device Industrial: Cardiac/angioplasty Liquid/well pressure measurement Catheters Automotive/machinery diagnostic
Early Stage Cancer Detection Using Laser-Induced Breakdown and Machine Learning
LIBS is the optical emission spectroscopy of a highly ionized gas (plasma) that can be produced by focusing an intense laser pulse on a target. UML researchers have shown that the LIBS method of cancer detection can be used to screen fluid cells in the same way it is used for tissue samples. They have shown that LIBS alone is not sufficient enough to accurately detect cancer, but when combined with machine learning it can be a viable procedure. They have also optimized the choice of substrate for LIBS for various diseases. Using machine learning methods, the team measured accuracy of up to 96% when discriminating between cancerous and healthy cells in mice with little preparation was needed for the tested samples. Applications • Detection of cancerous blood cells such as: - Epithelial Ovarian Cancer - Melanoma - Other asymptomatic cancers • Urinalysis to detect UTI’s and other infections • Spinal fluid tests for the detection of Alzheimer’s disease • Saliva analysis for lung and oral cancers • Blood sample testing for cardiovascular diseases
Lipid profiling for early detection of pancreatic cancer
We performed the initial retrospective clinical study based on 365 patient blood samples of pancreatic ductal adenocarcinoma (PDAC) and matched healthy controls, with the main focus on early stages (I-II) when the cancer is still resectable by surgical procedures. The study consisted of two steps: first “training” the system to recognize the lipid profile pattern of PDAC patients to create a clear distinction between cancer and healthy individuals, and then testing the results of that training. Cancer subjects including early stages were statistically differentiated from healthy controls with an accuracy 96-100%. Pancreatitis or diabetes mellitus did not influence the correct assignment. The whole methodology is based on accurate performance of multiple steps, including mainly the sample collection, storage, transport, and processing, followed by analysis using ultrahigh-performance supercritical fluid chromatography - mass spectrometry (UHPSFC/MS), followed by multivariate data analysis (MDA) of obtained absolute quantitative data for all the detectable lipids to create the comprehesive lipid profile (at least 51, but usually up to 500 or more lipid species). The method is suitable for high-throughput screening of the healthy individuals. 10,000 samples can be analyzed per year per 1 MS system and 1 operator. Further automatization could improve the performance.
Non-invasive blood glucose monitor
The non-invasive blood glucose monitor uses a technology called an optical bridge. The optical bridge uses the near-infrared wavelength range that includes the glucose absorption band at about 1620 nm. It sends two different wavelengths alternating in time into the earlobe, having the same extinction in the tissue background. One of the wavelengths is absorbed by glucose; the other is not. In order to separate the glucose signal from the background, the blood content of the sample volume is modulated by squeezing the sample. Almost all of the glucose is in the bloodstream. Without modulation, the glucose signal would be indistinguishable from the background. Signals are recorded while the blood content changes in the sample volume. A green wavelength measures the actual blood content independently. The ratio of the infrared differential change to the green change is the basis for the measurement. The method measures glucose in the bloodstream, which is of capital importance and which many other methods cannot do, as they are affected by the glucose in the interstitial fluid. The ultimate goal is a universal calibration that allows most people to use the device right out of the box.