A bioimpedance-based monitor for real-time detection and identification of secondary brain injury.

Secondary brain injury impacts patient prognosis and can lead to long-term morbidity and mortality in cases of trauma. Continuous monitoring of secondary injury in acute clinical settings is primarily limited to intracranial pressure (ICP); however, ICP is unable to identify essential underlying etiologies of injury needed to guide treatment (e.g. immediate surgical intervention vs medical management). Here we show that a novel intracranial bioimpedance monitor (BIM) can detect onset of secondary injury, differentiate focal (e.g. hemorrhage) from global (e.g. edema) events, identify underlying etiology and provide localization of an intracranial mass effect. We found in an in vivo porcine model that the BIM detected changes in intracranial volume down to 0.38 mL, differentiated high impedance (e.g. ischemic) from low impedance (e.g. hemorrhagic) injuries (p < 0.001), separated focal from global events (p < 0.001) and provided coarse 'imaging' through localization of the mass effect. This work presents for the first time the full design, development, characterization and successful implementation of an intracranial bioimpedance monitor. This BIM technology could be further translated to clinical pathologies including but not limited to traumatic brain injury, intracerebral hemorrhage, stroke, hydrocephalus and post-surgical monitoring.

IceSense Proof of Concept: Calibrating an Instrumented Figure Skating Blade to Measure On-Ice Forces.

Competitive figure skaters often suffer from overuse injuries, which may be due to the high impact forces endured during jump repetitions performed in practice and competition. However, to date, forces during on-ice figure skating have not been quantified due to technological limitations. The purpose of this study was to determine the optimal calibration procedure for a previously developed instrumented figure skating blade (IceSense). Initial calibration was performed by collecting data from the blade while 11 skaters performed off-ice jumps, landing on a force plate in the lab. However, mean peak force measurements from the blade were greater than the desired error threshold of ±10%. Therefore, we designed a series of controlled experiments which included measuring forces from a load cell rigidly attached to the top of the blade concurrently with strain data from the strain gauges on the blade. Forces were applied to the blade by adding weight to a drop tower or by manually applying force in a quasi-static manner. Both methods showed similar accuracy, though using the drop tower allowed precise standardization. Therefore, calibration was performed using the weighted drop method. This calibration was applied to strain gauge data from out-of-sample drop trials, resulting in acceptable estimates of peak force (less than 10% error). Using this calibration, we collected data on one figure skater and present results from an exemplar on-ice double flip jump. Using the IceSense device to quantify on-ice forces in a research setting may help inform training, technique, and equipment design.

Validation of a Laparoscopic Ferromagnetic Technology-based Vessel Sealing Device and Comparative Study to Ultrasonic and Bipolar Laparoscopic Devices.

INTRODUCTION: Ferromagnetic heating is a new electrosurgery energy modality that has proven effective in hemostatic tissue dissection as well as sealing and dividing blood vessels and vascularized tissue. The purpose of this study was to evaluate a ferromagnetic-based laparoscopic vessel sealing device with respect to sealing and dividing vessels and vascularized tissue and to compare performance against current vessel sealing technologies. MATERIALS AND METHODS: A laparoscopic vessel sealing device, Laparoscopic FMsealer (LFM), was studied for efficacy in sealing and dividing blood vessels and comparative studies against predicate ultrasonic, Harmonic Ace+(US), and/or bipolar, LigaSure 5 mm Blunt Tip and/or Maryland (BP), devices in vivo using a swine model and in vitro for comparison of seal burst pressure and reliability. Mann-Whitney and Student t test were used for statistical comparisons. RESULTS: In division of 10 cm swine small bowel mesentery in vivo, the laparoscopic FMsealer [12.4±1.8 sec (mean±SD)], was faster compared with US (26.8±2.5 s) and BP (30.0±2.7 s), P<0.05 LFM versus US and BP. Blinded histologic evaluation of 5 mm vessel seals in vivo showed seal lateral thermal spread to be superior in LFM (1678±433 µm) and BP (1796±337 µm) versus US (2032±387 µm), P<0.001. In vitro, seal burst strength and success of sealing 2 to 4 mm arteries were as follows (mean±SD mm Hg, % success burst strength >240 mm Hg): LFM (1079±494 mm Hg, 98.1% success) versus BP (1012±463, 99.0%), P=NS. For 5 to 7 mm arteries: LFM (1098±502 mm Hg, 95.3% success) versus BP (715±440, 91.8%), P<0.001 in burst strength and P=NS in % success. Five 60 kg female swine underwent 21-day survival studies following ligation of vessels ranging from 1 to 7 mm in diameter (n=186 total vessels). Primary seal was successful in 97%, 99% including salvage seals. There was no evidence of postoperative bleeding at sealed vessels at 21-day necropsy. CONCLUSION: The Laparoscopic FMsealer is an effective tool for sealing and dividing blood vessels and vascularized tissue and compares favorably to current technologies in clinically relevant end points.

Ferromagnetic Heating for Vessel Sealing and Division: Utility and Comparative Study to Ultrasonic and Bipolar Technologies.

INTRODUCTION: Vessel sealing technologies have improved surgical efficiency and outcomes. Ferromagnetic technology has potential utility in this area. The aim of this study was to evaluate ferromagnetic heating in sealing and dividing vessels. METHODS: A novel ferromagnetic (FM) sealer, FMsealer, was developed for sealing and dividing vessels. Using a swine in vivo model, the following endpoints were evaluated: (1) proof of concept, (2) 21-day survival surgery, and (3) comparison with ultrasonic (US) and/or bipolar (BP) devices for subjective outcomes. Seal burst strengths were measured in vitro. Mann-Whitney and Student's t test were used. RESULTS: After showing proof of concept, 5 swine underwent survival splenectomy, nephrectomy, hysterectomy, and mesenteric vessel division (arteries ranging from 1 to 7 mm in diameter) with necropsy after day 21 showing no evidence of surgical site bleeding. FM was equivalent to BP in tissue retention and superior to BP in spread/tissue desiccation, sticking, and charring (P ≤ .01). The FM was superior to US and BP in speed of 10 cm mesentery division (mean ± SD seconds): FM (12.9 ± 1.0 seconds), US (23.3 ± 4.4 seconds), BP (46.1 ± 5.2 seconds) (P ≤ .01 FM vs US or BP). Seal burst strength and success of sealing a 5-mm carotid artery were as follows (mean ± SD mmHg, % success burst strength >240 mm Hg): FM (710 ± 206 mm Hg, 94% success), US (848 ± 565 mm Hg, 79%), and BP (619 ± 373 mm Hg, 83%). CONCLUSION: Ferromagnetic heating is an effective and efficient technology for sealing and dividing of vessels. An initial prototype of the FMsealer compared favorably with commercially available products based on ultrasonic and bipolar technologies.

FPGA-based voltage and current dual drive system for high frame rate electrical impedance tomography.

Electrical impedance tomography (EIT) is used to image the electrical property distribution of a tissue under test. An EIT system comprises complex hardware and software modules, which are typically designed for a specific application. Upgrading these modules is a time-consuming process, and requires rigorous testing to ensure proper functioning of new modules with the existing ones. To this end, we developed a modular and reconfigurable data acquisition (DAQ) system using National Instruments' (NI) hardware and software modules, which offer inherent compatibility over generations of hardware and software revisions. The system can be configured to use up to 32-channels. This EIT system can be used to interchangeably apply current or voltage signal, and measure the tissue response in a semi-parallel fashion. A novel signal averaging algorithm, and 512-point fast Fourier transform (FFT) computation block was implemented on the FPGA. FFT output bins were classified as signal or noise. Signal bins constitute a tissue's response to a pure or mixed tone signal. Signal bins' data can be used for traditional applications, as well as synchronous frequency-difference imaging. Noise bins were used to compute noise power on the FPGA. Noise power represents a metric of signal quality, and can be used to ensure proper tissue-electrode contact. Allocation of these computationally expensive tasks to the FPGA reduced the required bandwidth between PC, and the FPGA for high frame rate EIT. In 16-channel configuration, with a signal-averaging factor of 8, the DAQ frame rate at 100 kHz exceeded 110 frames s (-1), and signal-to-noise ratio exceeded 90 dB across the spectrum. Reciprocity error was found to be for frequencies up to 1 MHz. Static imaging experiments were performed on a high-conductivity inclusion placed in a saline filled tank; the inclusion was clearly localized in the reconstructions obtained for both absolute current and voltage mode data.

Intracranial electrical impedance tomography: a method of continuous monitoring in an animal model of head trauma.

BACKGROUND: Electrical impedance tomography (EIT) is a method that can render continuous graphical cross-sectional images of the brain's electrical properties. Because these properties can be altered by variations in water content, shifts in sodium concentration, bleeding, and mass deformation, EIT has promise as a sensitive instrument for head injury monitoring to improve early recognition of deterioration and to observe the benefits of therapeutic intervention. This study presents a swine model of head injury used to determine the detection capabilities of an inexpensive bedside EIT monitoring system with a novel intracranial pressure (ICP)/EIT electrode combination sensor on induced intraparenchymal mass effect, intraparenchymal hemorrhage, and cessation of brain blood flow. Conductivity difference images are shown in conjunction with ICP data, confirming the effects. METHODS: Eight domestic piglets (3-4 weeks of age, mean 10 kg), under general anesthesia, were subjected to 4 injuries: induced intraparenchymal mass effect using an inflated, and later, deflated 0.15-mL Fogarty catheter; hemorrhage by intraparenchymal injection of 1-mL arterial blood; and ischemia/infarction by euthanasia. EIT and ICP data were recorded 10 minutes before inducing the injury until 10 minutes after injury. Continuous EIT and ICP monitoring were facilitated by a ring of circumferentially disposed cranial Ag/AgCl electrodes and 1 intraparenchymal ICP/EIT sensor electrode combination. Data were recorded at 100 Hz. Two-dimensional tomographic conductivity difference (Δσ) images, rendered using data before and after an injury, were displayed in real time on an axial circular mesh. Regions of interest (ROI) within the images were automatically selected as the upper or lower 5% of conductivity data depending on the nature of the injury. Mean Δσ within the ROIs and background were statistically analyzed. ROI Δσ was compared with the background Δσ after an injury event using an unpaired, unequal variance t test. Conductivity change within an ROI after injury was likewise compared with the same ROI before the injury making use of unpaired t tests with unequal variance. RESULTS: Eight animal subjects were studied, each undergoing 4 injury events including euthanasia. Changes in conductivity due to injury showed expected pathophysiologic effects in an ROI identified within the middle of the left hemisphere; this localization is reasonable given the actual site of injury (left hemisphere) and spatial warping associated with estimating a 3-dimensional conductivity distribution in 2-dimensional space. Results are shown as mean ± 1 SD. When averaged across all 8 animals, balloon inflation caused the mean Δσ within the ROI to shift by -11.4 ± 10.9 mS/m; balloon deflation by +9.4 ± 8.8 mS/m; blood injection by +19.5 ± 11.5 mS/m; death by -12.6 ± 13.2 mS/m. All induced injuries were detectable to statistical significance (P < 0.0001). CONCLUSION: This study confirms that the bedside EIT system with ICP/EIT combination sensor can detect induced trauma. Such a technique may hold promise for further research in the monitoring and management of traumatically brain-injured individuals.

FPGA Based High Speed Data Acquisition System for Electrical Impedance Tomography.

Electrical Impedance Tomography (EIT) systems are used to image tissue bio-impedance. EIT provides a number of features making it attractive for use as a medical imaging device including the ability to image fast physiological processes (>60 Hz), to meet a range of clinical imaging needs through varying electrode geometries and configurations, to impart only non-ionizing radiation to a patient, and to map the significant electrical property contrasts present between numerous benign and pathological tissues. To leverage these potential advantages for medical imaging, we developed a modular 32 channel data acquisition (DAQ) system using National Instruments' PXI chassis, along with FPGA, ADC, Signal Generator and Timing and Synchronization modules. To achieve high frame rates, signal demodulation and spectral characteristics of higher order harmonics were computed using dedicated FFT-hardware built into the FPGA module. By offloading the computing onto FPGA, we were able to achieve a reduction in throughput required between the FPGA and PC by a factor of 32:1. A custom designed analog front end (AFE) was used to interface electrodes with our system. Our system is wideband, and capable of acquiring data for input signal frequencies ranging from 100 Hz to 12 MHz. The modular design of both the hardware and software will allow this system to be flexibly configured for the particular clinical application.

3D electric impedance tomography reconstruction on multi-core computing platforms.

This manuscript presents results relative to the optimization of 3D impedance tomography reconstruction algorithms for execution on multi-core computing platforms. Speed-ups obtainable by the use of modern computing architectures and by an optimized implementation allow the use of much finer FEM meshes in the forward model, leading ultimately to a better image quality. We formulate the reconstruction as widely common in the EIT community: as a non-linear, least squares, Tikhonov regularized, discrete inverse problem. The forward model is based on a FEM solver that implements the Complete Electrode Model. By profiling a plain but careful MATLAB implementation of such an algorithm, we find that, in problems with mesh sizes in the order of 100.000 nodes, typically 95% of the computing time is spent in solving the forward problem and in computing the Jacobian matrix from the forward solutions. We have focused on optimizing the execution of these two functions, and we report relative results. On an octal Xeon 5355 based PC, on problems with forward meshes with a number of nodes in the range of 59,000 nodes to 146,000 nodes, the optimized algorithm has a speed-up of up to 7 times compared to an equivalent MATLAB implementation that makes use of the multithreading capabilities of the platform.

Arbitrary geometry patient interfaces for breast cancer detection and monitoring with electrical impedance tomography.

Electrical impedance tomography (EIT) is a promising technology enabling the detection or observation of many biological processes. This is typically accomplished by applying currents at known locations on an outer surface (in this case skin) and measuring voltages at other locations. This information is then used to determine electrical properties of tissue found between the electrodes by solving the associated Laplace equation. Such problems depend upon knowing the exact boundary conditions (BC). Unfortunately BCs are not always easily determined and approximations are accepted out of necessity due to problem complexity or time constraints. The EIT group at Dartmouth College has developed two new patient interfaces for breast cancer detection and monitoring both of which speed acquisition time and allow for precision BC information in natural and arbitrary geometries. Preliminary experimental results are presented.