Daniel L. Ewert

Mock circulatory system for testing cardiovascular devices

A need exists for a mock ventricle and vasculature that behaves in a physiological manner for testing cardiac devices in normal pathologic states. To this end, an integrated mock cardiovascular system consisting of a mock atrium, mock ventricle, and mock systemic and coronary vasculature was developed specifically for testing ventricular assist devices. This surgically-equivalent test configuration enables atrial or ventricular apex inflow and aortic outflow cannulation connections. The objective of this study was to evaluate the mock ventricle for its pressure-volume (PV) relationships under normal, heart failure, and partial recovery test conditions. The PV relationships were investigated by varying ventricular volume over a wide range via atrial (preload) and aortic (afterload) occlusions. The mock circulation was set-up to mimic physiologically-equivalent normal, heart failure, and partial recovery test conditions. Results showed that the mock PV loops and the end-systolic PV relationships were representative of the physiological behavior characteristics of the natural heart for these test conditions. Although mock circulations cannot replace in vivo models, this configuration should be well suited for developing experimental protocols, testing device feedback control algorithms, investigating velocity profiles, and training surgical staff with operational procedures of assist devices.

Design and In Vivo Test of a Batteryless and Fully Wireless Implantable Asynchronous Pacing System

Goal: The aim of this study is to develop a novel fully wireless and batteryless technology for cardiac pacing. Methods: This technology uses radio frequency (RF) energy to power the implanted electrode in the heart. An implantable electrode antenna was designed for 1.2 GHz; then, it was tested in vitro and, subsequently, integrated with the rectifier and pacing circuit to make a complete electrode. The prototype implanted electrode was tested in vivo in an ovine subject, implanting it on the epicardial surface of the left ventricle. The RF energy, however, was transmitted to the implanted electrode using a horn antenna positioned 25 cm above the thorax of the sheep. Results: It was demonstrated that a small implanted electrode can capture and harvest enough safe recommended RF energy to achieve pacing. Electrocardiogram signals were recorded during the experiments, which demonstrated asynchronous pacing achieved at three different rates. Conclusion: These results show that the proposed method has a great potential to be used for stimulating the heart and provides pacing, without requiring any leads or batteries. It hence has the advantage of potentially lasting indefinitely and may never require replacement during the life of the patient. Significance: The proposed method brings forward transformational possibilities in wireless cardiac pacing, and also in powering up the implantable devices.

A technique for sequential segmental neuromuscular stimulation with closed loop feedback control.

In dynamic myoplasty, dysfunctional muscle is assisted or replaced with skeletal muscle from a donor site. Electrical stimulation is commonly used to train and animate the skeletal muscle to perform its new task. Due to simultaneous tetanic contractions of the entire myoplasty, muscles are deprived of perfusion and fatigue rapidly, causing long-term problems such as excessive scarring and muscle ischemia. Sequential stimulation contracts part of the muscle while other parts rest, thus significantly improving blood perfusion. However, the muscle still fatigues. In this article, we report a test of the feasibility of using closed-loop control to economize the contractions of the sequentially stimulated myoplasty. A simple stimulation algorithm was developed and tested on a sequentially stimulated neo-sphincter designed from a canine gracilis muscle. Pressure generated in the lumen of the myoplasty neo-sphincter was used as feedback to regulate the stimulation signal via three control parameters, thereby optimizing the performance of the myoplasty. Additionally, we investigated and compared the efficiency of amplitude and frequency modulation techniques. Closed-loop feedback enabled us to maintain target pressures within 10% deviation using amplitude modulation and optimized control parameters (correction frequency = 4 Hz, correction threshold = 4%, and transition time = 0.3 s). The large-scale stimulation/feedback setup was unfit for chronic experimentation, but can be used as a blueprint for a small-scale version to unveil the theoretical benefits of closed-loop control in chronic experimentation.

Electric analog model of the aortic valve for calculation of continuous beat-to-beat aortic flow using a pressure gradient.

The objective was to develop a technique for calculating continuous, beat-to-beat aortic flow (AoF) using only left ventricular pressure (LVP) and aortic pressure (AoP). An electric analog model of the aortic valve was developed that includes resistance (R), inertance (L), and compliance (C) parameters, and resulting second order differential equations were derived. Aortic flow, AoP, and LVP recorded in eight subjects during a 5 day period and during lower body negative pressure (LBNP) were used to validate the model. Resistance, L, and C were estimated using a least-squares fit to the measured AoF on day 0 and during 0 mm Hg LBNP. For days 1-4, AoF was calculated using measured values of AoP and LVP and the R, L, and C values from day 0. Similarly, for LBNP, AoF was calculated using measured values of AoP and LVP, and the R, L, and C values from 0 mm Hg LBNP. The calculated and measured AoF were compared. Differences in cardiac output between the calculated and measured flows were less than 13.1+/-17% across days and under minor altered physiologic conditions (LBNP). Waveform morphology for the calculated AoF also agreed well with the measured AoF. Spectral analysis showed differences in magnitude and phase between measured and calculated aortic flow for the first five harmonics across days, less than 20+/-6% and 25+/-14 degrees, respectively. Preliminary evaluation indicates that our model works well for calculating flow through a biologic valve using LVP and AoP. We speculate that it may perform better for a mechanical valve, and if so it may be possible to develop an instrumented mechanical valve capable of continuous LVP, AOP, and AoF measurements.

In Vitro Evaluation of Control Strategies for an Artificial Vasculature Device

Ventricular assist devices (VADs) have been used successfully as a bridge to transplant in heart failure patients by unloading ventricular volume and restoring the circulation. An artificial vasculature device (AVD) that may better facilitate myocardial recovery than VAD by controlling the afterload seen by the ejecting heart is being developed. The AVD concept is to enable any user-defined input impedance (IM) with resistance (R) and compliance (C) components. In this study, a pulse duplicator was used to test the efficacy of the AVD concept for two control strategies in an adult mock circulation: (1) R-C in series and (2) 2-element Windkessel (R-C in parallel) using instantaneous impedance position control (IIPC) to maintain a desired value or profile of R and C. In vitro experiments were performed and the resulting cardiovascular pressures, volumes, flows, and the afterload (R and C) seen by the LV during ejection for simulated cardiac failure were recorded and analyzed. Our results indicate that setting the AVD to lower IM reduced LV volume and pressure, restored LV stroke volume, and increased coronary flow. The IIPC control algorithms are better suited to maintain any instantaneous IM or an IM profile, but are susceptible to measurement noise.

Can a linear electrical analog model of a mechanical valve predict flow by using a pressure gradient

The objective was to determine whether a previously developed technique for biological aortic valves could predict flow through a mechanical valve. An electrical analog model of the aortic valve that includes compliance, resistance, and inertance parameters, and corresponding second order differential equations was used to predict flow given a pressure gradient, as previously reported. Simulated pressures and flow were recorded by using a pulse duplicator system. The heart rate was varied from 60 to 180 bpm, and the stroke volume was varied from 22 to 67 cc. Resistance, inertance, and compliance parameters of the governing differential equation were estimated by using a least-squares fit to the measured flow at 120 bpm and 50 cc stroke volume. By using these parameter estimates, flow was calculated for other heart rates and stroke volumes. To achieve a better flow prediction, a nonlinear filter (third order polynomial range calibration equation) was applied to the output of the linear model (flow). The mean error, full-scale error, and spectral error in magnitude and phase between measured and predicted flow were compared. Error in mean flow ranged from 3% at medium flow rates to 90% at low flow rates. The maximum and minimum full scale errors were 12% and 5%, respectively. Error in the harmonics of measured and calculated flow ranged from 0% to 55%. Larger errors were usually present at the higher harmonics. The agreement between measured and calculated flow was better at normal and high flows but rather poor at low flows. The nonlinear filter (range calibration equation) was unable to account for the discrepancies between the measured and calculated flow over all flow ranges. It seems that this linear model and nonlinear filter have limited application, and an alternate nonlinear approach may produce better results.

Control strategies for afterload reduction with an artificial vasculature device.

Ventricular assist devices (VADs) have been used successfully as a bridge to transplant in heart failure patients by unloading ventricular volume and restoring the circulation. An artificial vasculature device (AVD) is being developed that may better facilitate myocardial recovery than VAD by controlling the afterload experienced by the native heart and controlling the pulsatile energy entering into the arterial system from the device, potentially reconditioning the arterial system properties. The AVD is a valveless, 80 ml blood chamber with a servo-controlled pusher plate connected to the ascending aorta by a vascular graft. Control algorithms for the AVD were developed to maintain any user-defined systemic input impedance (IM) including resistance, elastance, and inertial components. Computer simulation and mock circulation models of the cardiovascular system were used to test the efficacy of two control strategies for the AVD: 1) average impedance position control (AIPC)—to maintain an average value of resistance during left ventricular (LV) systole and 2) instantaneous impedance force feedback (IIFF) and position control (IIPC)—to maintain a desired value or profile of resistance and compliance. Computer simulations and mock loop tests were performed to predict resulting cardiovascular pressures, volumes, flows, and the resistance and compliance experienced by the native LV during ejection for simulated normal, failing, and recovering LV. These results indicate that the LV volume and pressure decreased, and the LV stroke volume increased with decreasing IM, resulting in an increased ejection fraction. Although the AIPC algorithm is more stable and can tolerate higher levels of sensor errors and noise, the IIFF and IIPC control algorithms are better suited to maintain any instantaneous IM or an IM profile. The developed AVD impedance control algorithms may be implemented with current VADs to promote myocardial recovery and facilitate weaning.

Viscoelastic influence on wall and baroreceptors of rabbit carotid sinus.

Abstract This study examined multifiber baroreceptor nerve activity (BNA) as a function of carotid sinus wall distension in 19 rabbits. Analysis estimated mechanical or viscoelastic properties of the sinus wall and their influence on BNA. In six sinuses, properties were altered by treatment with the enzyme protease to remove the endothelium and with nifedipine to passively relax smooth muscle. Properties were estimated from dynamic and steady state wall response to a 45 mm Hg step increase and decrease in intrasinus pressure (ISP) of 20 min. Control wall response had fast and slow (creep) portions with a viscosity increase from 1,370 N(s)/m to 17,864 N(s)/m during step-up in ISP. Wall elasticity averaged 77 N/m; which estimated the relationship of force and change in steady state response. Control BNA response also had fast and slow (resetting) portions. A BNA and wall response relationship (BNA/m) was defined as transduction-gain (T-G) with proportional and dynamic components. In the subgroup, wall creep and baroreceptor resetting were abolished by protease treatment, suggesting an endothelial mediator which influenced sinus smooth muscle. Histology data indicated enzyme damage was limited to tunica intima tissues, and nifedipine did not block Ca2+ channels on neural structures. By comparison of responses before and after treatments the proportional component of T-G was equated to an elastic influence (1/E), with E = 7.5 × 10−6 m/BNA, while the dynamic component was equated to a viscous influence (1/V), with V = 1.53 × 10−4 m(s)/BNA. A simple but fundamental relationship for baroreceptor-tissue linkages was estimated by BNA/m = 1/(Vs + E), a first-order transfer function.

A compact printed Van Atta Array with zero-phase CRLH transmission lines

A key component in the design of a printed Van Array is the requirement of the transmission line (TL) interconnects between the elements to be a factor of the operating wavelength. This results in interconnects that introduce a 2π phase shift. Traditionally, meander-lines have been used to design these interconnects; however, one drawback is the large space required for the layout. In this paper, a more compact Van Atta array that uses zero-phase composite right/left-handed TLs instead of meander-lines is presented. The result is a Van Array array that is 34.0% smaller at the operating frequency of 2.43 GHz. For validation, simulations are compared to measurements of several prototypes.

A far-field radio-frequency experimental exposure system with unrestrained mice

Many studies have been performed on exploring the effects of radio-frequency (RF) energy on biological function in vivo. In particular, gene expression results have been inconclusive due, in part, to a lack of a standardized experimental procedure. This research describes a new far field RF exposure system for unrestrained murine models that reduces experimental error. The experimental procedure includes the materials used, the creation of a patch antenna, the uncertainty analysis of the equipment, characterization of the test room, experimental equipment used and setup, power density and specific absorption rate experiment, and discussion. The result of this research is an experimental exposure system to be applied to future biological studies.