Intracranial Pressure Sensor and Valve to Control Hydrocephalus.

Hydrocephalus is a neurological condition that can result from trauma, hemorrhage, cancer, and infection. To control the intracranial pressure (ICP) a shunt is implanted to drain the cerebro-spinal fluid (CSF). We are working to develop an implantable pressure sensor. When the ICP is too high it will open a valve to relieve the ICP. When the ICP is too low, it will close the valve.

How to Invent New Medical Devices.

Further develop strong engineering skills, supplement with knowledge of medicine and biology. Acquire clinical problems requiring solutions from medical and biological professionals. Form design teams to solve those problems: review the literature, confer with experts, brainstorm all the possibilities, select the most promising solution, build it in the lab, test it, iterate, publish.

A Sleep Apnea Therapy Device Uses No Added Pressure.

Sleep Apnea is a common sleeping disorder that affects over 25 million Americans. Due to the complex nature of sleep apnea, and the human body, neither an effective nor comfortable treatment option for sleep apnea has been developed. Accordingly, we describe a novel alternative to current sleep apnea therapies, including CPAP therapy. A comfortable device for treating sleep apnea incorporates a mask, a flexible hose and a chamber for collecting expired air containing CO2. A sensor detects apnea and a control system automatically adjusts the amount of rebreathed CO2 minimize apnea and also minimize arousal.

Video Voiding Device for Diagnosing Lower Urinary Tract Dysfunction in Men.

We introduce a novel diagnostic Visual Voiding Device (VVD), which has the ability to visually document urinary voiding events and calculate key voiding parameters such as instantaneous flow rate. The observation of the urinary voiding process along with the instantaneous flow rate can be used to diagnose symptoms of Lower Urinary Tract Dysfunction (LUTD) and improve evaluation of LUTD treatments by providing subsequent follow-up documentations of voiding events after treatments. The VVD enables a patient to have a urinary voiding event in privacy while a urologist monitors, processes, and documents the event from a distance. The VVD consists of two orthogonal cameras which are used to visualize urine leakage from the urethral meatus, urine stream trajectory, and its break-up into droplets. A third, lower back camera monitors a funnel topped cylinder where urine accumulates that contains a floater for accurate readings regardless of the urine color. Software then processes the change in level of accumulating urine in the cylinder and the visual flow properties to calculate urological parameters. Video playback allows for reexamination of the voiding process. The proposed device was tested by integrating a mass flowmeter into the setup and simultaneously measuring the instantaneous flow rate of a predetermined voided volume in order to verify the accuracy of VVD compared to the mass flowmeter. The VVD and mass flowmeter were found to have an accuracy of ±2 and ±3% relative to full scale, respectively. A VVD clinical trial was conducted on 16 healthy male volunteers ages 23-65.

A Novel Intracranial Pressure Readout Circuit for Passive Wireless LC Sensor.

We present a wide frequency range, low cost, wireless intracranial pressure monitoring system, which includes an implantable passive sensor and an external reader. The passive sensor consists of two spiral coils and transduces the pressure change to a resonant frequency shift. The external portable reader reads out the sensor's resonant frequency over a wide frequency range (35 MHz-2.7 GHz). We propose a novel circuit topology, which tracks the system's impedance and phase change at a high frequency with low-cost components. This circuit is very simple and reliable. A prototype has been developed, and measurement results demonstrate that the device achieves a suitable measurement distance (>2 cm), sufficient sample frequency (>6 Hz), fine resolution, and good measurement accuracy for medical practice. Responsivity of this prototype is 0.92 MHz/mmHg and resolution is 0.028 mmHg. COMSOL specific absorption rate simulation proves that this system is safe. Considerations to improve the device performance have been discussed, which include the size of antenna, the power radiation, the Analog-to-digital converter (ADC) choice, and the signal processing algorithm.

Invasive and noninvasive means of measuring intracranial pressure: a review.

Measurement of intracranial pressure (ICP) can be invaluable in the management of critically ill patients. Cerebrospinal fluid is produced by the choroid plexus in the brain ventricles (a set of communicating chambers), after which it circulates through the different ventricles and exits into the subarachnoid space around the brain, where it is reabsorbed into the venous system. If the fluid does not drain out of the brain or get reabsorbed, the ICP increases, which may lead to brain damage or death. ICP elevation accompanied by dilatation of the cerebral ventricles is termed hydrocephalus, whereas ICP elevation accompanied by normal or small ventricles is termed idiopathic intracranial hypertension. OBJECTIVE: We performed a comprehensive literature review on how to measure ICP invasively and noninvasively. APPROACH: This review discusses the advantages and disadvantages of current invasive and noninvasive approaches. MAIN RESULTS: Invasive methods remain the most accurate at measuring ICP, but they are prone to a variety of complications including infection, hemorrhage and neurological deficits. Ventricular catheters remain the gold standard but also carry the highest risk of complications, including difficult or incorrect placement. Direct telemetric intraparenchymal ICP monitoring devices are a good alternative. Noninvasive methods for measuring and evaluating ICP have been developed and classified in five broad categories, but have not been reliable enough to use on a routine basis. These methods include the fluid dynamic, ophthalmic, otic, and electrophysiologic methods, as well as magnetic resonance imaging, transcranial Doppler ultrasonography (TCD), cerebral blood flow velocity, near-infrared spectroscopy, transcranial time-of-flight, spontaneous venous pulsations, venous ophthalmodynamometry, optical coherence tomography of retina, optic nerve sheath diameter (ONSD) assessment, pupillometry constriction, sensing tympanic membrane displacement, analyzing otoacoustic emissions/acoustic measure, transcranial acoustic signals, visual-evoked potentials, electroencephalography, skull vibrations, brain tissue resonance and the jugular vein. SIGNIFICANCE: This review provides a current perspective of invasive and noninvasive ICP measurements, along with a sense of their relative strengths, drawbacks and areas for further improvement. At present, none of the noninvasive methods demonstrates sufficient accuracy and ease of use while allowing continuous monitoring in routine clinical use. However, they provide a realizable ICP measurement in specific patients especially when invasive monitoring is contraindicated or unavailable. Among all noninvasive ICP measurement methods, ONSD and TCD are attractive and may be useful in selected settings though they cannot be used as invasive ICP measurement substitutes. For a sufficiently accurate and universal continuous ICP monitoring method/device, future research and developments are needed to integrate further refinements of the existing methods, combine telemetric sensors and/or technologies, and validate large numbers of clinical studies on relevant patient populations.

Feasibility and usability of a wearable orthotic for stroke survivors with hand impairment.

PURPOSE: The concept of a vibrating wristband, to improve dextrous hand function of stroke survivors, was recently proposed with clinical results and is referred to as 'TheraBracelet' in this paper. The purpose of this study was to demonstrate feasibility of a portable, wearable TheraBracelet, and to apply usability evaluation techniques to assess potential demands of TheraBracelet and to identify critical improvement needs of the prototype. METHOD: A prototype was developed with a vibrating element housed in an elastic wristband and connected to a wearable electronics box via a cable. Expectation for TheraBracelet and evaluation of the prototype were obtained from 10 chronic stroke survivors using surveys before and after using the prototype and House of Quality analysis. RESULTS: The survey for expectation showed stroke survivors' willingness to try out TheraBracelet at a low cost. The survey evaluating the prototype showed that the current prototype was overall satisfactory with a mean rating of 3.7 out of 5. The House of Quality analysis revealed that the priority improvement needs for the prototype are to improve clinical knowledge on long-term effectiveness, reduce cost, ease donning/doffing and waterproof. CONCLUSIONS: This study presents a potential for a low-cost wearable hand orthotic likable by stroke survivors. Implications for Rehabilitation Feasibility for a portable wearable wristband-type hand orthotic was demonstrated. The survey showed stroke survivors are willing to try such an orthotic at low cost. The current prototype was rated overall satisfactory by stroke survivors. This study provides a potential for a low-cost wearable hand orthotic likable by stroke survivors.

Application of vibration to wrist and hand skin affects fingertip tactile sensation.

A recent study showed that fingertip pads' tactile sensation can improve by applying imperceptible white-noise vibration to the skin at the wrist or dorsum of the hand in stroke patients. This study further examined this behavior by investigating the effect of both imperceptible and perceptible white-noise vibration applied to different locations within the distal upper extremity on the fingertip pads' tactile sensation in healthy adults. In 12 healthy adults, white-noise vibration was applied to one of four locations (dorsum hand by the second knuckle, thenar and hypothenar areas, and volar wrist) at one of four intensities (zero, 60%, 80%, and 120% of the sensory threshold for each vibration location), while the fingertip sensation, the smallest vibratory signal that could be perceived on the thumb and index fingertip pads, was assessed. Vibration intensities significantly affected the fingertip sensation (P < 0.01) in a similar manner for all four vibration locations. Specifically, vibration at 60% of the sensory threshold improved the thumb and index fingertip tactile sensation (P < 0.01), while vibration at 120% of the sensory threshold degraded the thumb and index fingertip tactile sensation (P < 0.01) and the 80% vibration did not significantly change the fingertip sensation (P > 0.01), all compared with the zero vibration condition. This effect with vibration intensity conforms to the stochastic resonance behavior. Nonspecificity to the vibration location suggests the white-noise vibration affects higher level neuronal processing for fingertip sensing. Further studies are needed to elucidate the neural pathways for distal upper extremity vibration to impact fingertip pad tactile sensation.

An MRI-compatible hand sensory vibrotactile system.

Recently, the application of vibrotactile noise to the wrist or back of the hand has been shown to enhance fingertip tactile sensory perception (Enders et al 2013), supporting the potential for an assistive device worn at the wrist, that generates minute vibrations to help the elderly or patients with sensory deficit. However, knowledge regarding the detailed physiological mechanism behind this sensory improvement in the central nervous system, especially in the human brain, is limited, hindering progress in development and use of such assistive devices. To enable investigation of the impact of vibrotactile noise on sensorimotor brain activity in humans, a magnetic resonance imaging (MRI)-compatible vibrotactile system was developed to provide vibrotactile noise during an MRI of the brain. The vibrotactile system utilizes a remote (outside the MR room) signal amplifier which provides a voltage from -40 to +40 V to drive a 12 mm diameter piezoelectric vibrator (inside the MR room). It is portable and is found to be MRI-compatible which enables its use for neurologic investigation with MRI. The system was also found to induce an improvement in fingertip tactile sensation, consistent with the previous study.

Miniature ambulatory skin conductance monitor and algorithm for investigating hot flash events.

A skin conductance monitoring system was developed and shown to reliably acquire and record hot flash events in both supervised laboratory and unsupervised ambulatory conditions. The 7.2 × 3.8 × 1.2 cm(3) monitor consists of a disposable adhesive patch supporting two hydrogel electrodes and a reusable, miniaturized, enclosed electronic circuit board that snaps onto the electrodes. The monitor measures and records the skin conductance for seven days without external wires or telemetry and has an event marker that the subject can press whenever a hot flash is experienced. The accuracy of the system was demonstrated by comparing the number of hot flashes detected by algorithms developed during this research with the number identified by experts in hot flash studies. Three methods of detecting hot flash events were evaluated, but only two were fully developed. The two that were developed were an artificial neural network and a matched filter technique with multiple kernels implemented as a sliding form of the Pearson product-moment correlation coefficient. Both algorithms were trained on a 'development' cohort of 17 women and then validated using a second similar 'validation' cohort of 20. All subjects were between the ages of 40 and 60 and self-reported ten or more hot flashes per day over a three day period. The matched filter was the most accurate with a mean sensitivity of 0.92 and a mean specificity of 0.90 using the data from the development cohort and a mean sensitivity of 0.92 and a mean specificity of 0.87 using the data from the validation cohort. The matched filter was the method implemented in our processing software.

TaserX26 current increases with dart depth.

The TaserX26 output current waveform consists of an arc phase and a stimulation phase, which is responsible for electromuscular stimulation. We modeled the current discharge during the stimulation phase using a simplified overdamped series R-L-C circuit. The model provides a reasonable approximation to the TaserX26 current waveform and explains the changes in the peak current and rise and fall time constants due to load variations. We simulated a physiological load using a 0.2% saline solution in a 75 × 30 × 17.2 cm fish tank to represent a supine human torso with resistivity similar to skeletal muscles. The peak current and load resistance varied more with the depth of the Taser darts in saline than with their distance of separation. Experiments performed on three pigs confirmed the decrease in resistance and increase in current with the depth of the Taser dart in the body. An R-C circuit with a time constant of about 2 ms was used to measure the variation of the Taser in stimulating cardiac cells. The Taser is 2.05 times more likely to stimulate the cardiac cell when the darts penetrate 9 mm into the load as compared to when they were just touching the load.

Design of low-cost portable ultrasound systems: review.

Ultrasound continues to be one of the major imaging modalities used for the diagnosis and treatment of a number of medical conditions. Therefore emphasis on innovation is continually increasing the quality of the ultrasound systems. However focus is just beginning to shift into the low-cost and portable applications of ultrasound. These systems present interesting constraints which must be considered to transform a standalone system into a portable version. This review takes a look at some of the attempts which have been published, as well as some of the issues which have still yet to be resolved. In conclusion, low-cost portable ultrasound has the capability to be developed and commercialized, but until a suitable replacement to piezoelectric crystals has been developed (possibly CMUTs?) low-cost portable ultrasound system will be held back by the high cost burden associated with the cost of piezoceramics.

Medical devices for developing countries: design constraints and approaches.

Medical devices intended for use in developing countries have certain differences compared to those used in developed countries. Thus, many of the medical devices built for developed countries may not be compatible with the environment in developing countries. In this specific case study we consider the respiratory problems in India and elucidate design constraints and approaches for the development of medical devices to diagnose them.

Battery power comparison to charge medical devices in developing countries.

Many people in developing countries cannot afford or rely on certain modes of electricity. We establish the reasonability of relying on lead-acid batteries, 9 V alkaline batteries, and lithium-ion batteries for charging low-voltage medical equipment. Based on the research and tests we conducted, we determined that using these battery types to charge medical devices truly is a reasonable solution.

Electronic medical record systems for developing countries: review.

The majority of the focus related to the modernization of medical records is placed on developed countries. However, developing countries are also progressing from paper-based records to electronic records. The requirements of their systems can be dramatically different from those of the developed world. This paper describes briefly the benefits of EMRs in developing countries. It focuses on the basic EMR information, including types of EMRs, components of EMRs, and already existing case studies, in order to establish which EMR systems would be feasible and effective for specific situations.

Global engineering education initiative through student organization.

Engineering is becoming a more globally aware discipline that is revolutionizing the way individuals interact internationally. Engineering World Health (EWH) - Madison Chapter is a student-initiated organization that has developed opportunities to facilitate both local and global engineering education. Through EWH - Madison Chapter student-initiated activities, this organization has developed an interface between Traditional, Technical, and Translational education mediums. This study attests to the development of global engineering programs in the context of biomedical applications.

Tumor boundary estimation through time-domain peaks monitoring: numerical predictions and experimental results in tissue-mimicking phantoms.

A method to estimate the boundary of a tumor using an interstitial microwave probe was evaluated in numerical and phantom models. This method utilizes time-domain signal reflection from the tumor/liver interface to provide information about tumor boundary in both radial and axial directions. Using computational experiments, tumors with radial diameters up to 25 mm were estimated with less than 1 mm error. Axial diameters were estimated with at most 5 mm error. Accuracy seemed to increase with radial diameter but decreased with axial diameter. Phantom experiments confirmed the computational results. These early results indicate that the proposed method may be used to estimate tumor boundary in both radial and axial dimensions without imaging. The technique may also be applicable in other situations that contain dielectric contrast between a volume of tissue and its background, such as monitoring tumor ablation growth. Additional work is needed to validate and optimize this method in tumor models.

An optimal sliding choke antenna for hepatic microwave ablation.

Microwave ablation (MWA) is a minimally invasive technique increasingly used for thermal therapy of liver tumors. Effective MWA requires efficient interstitial antennas that destroy tumors and a margin of healthy tissue, in situ, while minimizing damage to the rest of the organ. Previously, we presented a method for optimizing MWA antenna designs by coupling finite element method models of antennas with a real-coded, multiobjective genetic algorithm. We utilized this procedure to optimize the design of a minimally invasive choke antenna that can be used to create near-spherical ablation zones of adjustable size (radius 1-2 cm) by adjusting treatment durations and a sliding structure of the antenna. Computational results were validated with experiments in ex vivo bovine liver. The optimization procedure yielded antennas with reflection coefficients below -30 dB, which were capable of creating spherical ablation zones up to 2 cm in radius using 100 W input power at 2.45 GHz with treatment durations under 2 min.

Electrical conductivity measurement of excised human metastatic liver tumours before and after thermal ablation.

We measured the ex vivo electrical conductivity of eight human metastatic liver tumours and six normal liver tissue samples from six patients using the four electrode method over the frequency range 10 Hz to 1 MHz. In addition, in a single patient we measured the electrical conductivity before and after the thermal ablation of normal and tumour tissue. The average conductivity of tumour tissue was significantly higher than normal tissue over the entire frequency range (from 4.11 versus 0.75 mS cm(-1) at 10 Hz, to 5.33 versus 2.88 mS cm(-1) at 1 MHz). We found no significant correlation between tumour size and measured electrical conductivity. While before ablation tumour tissue had considerably higher conductivity than normal tissue, the two had similar conductivity throughout the frequency range after ablation. Tumour tissue conductivity changed by +25% and -7% at 10 Hz and 1 MHz after ablation (0.23-0.29 at 10 Hz, and 0.43-0.40 at 1 MHz), while normal tissue conductivity increased by +270% and +10% at 10 Hz and 1 MHz (0.09-0.32 at 10 Hz and 0.37-0.41 at 1 MHz). These data can potentially be used to differentiate tumour from normal tissue diagnostically.