Mirko Meboldt

SPALTEN Matrix — Product Development Process on the Basis of Systems Engineering and Systematic Problem Solving

The SPALTEN Matrix is a holistic product development process approach, which combines system engineering, the phases of the product development process and a systematic problem solving to one successful approach to handle complex product development processes. The SPALTEN-Matrix is the process backbone and cooperation, coordination and information platform for the product development process. This approach provides a long term planning and situation oriented problem solving during the product development process.

A Soft Total Artificial Heart—First Concept Evaluation on a Hybrid Mock Circulation

The technology of 3D-printing has allowed the production of entirely soft pumps with complex chamber geometries. We used this technique to develop a completely soft pneumatically driven total artificial heart from silicone elastomers and evaluated its performance on a hybrid mock circulation. The goal of this study is to present an innovative concept of a soft total artificial heart (sTAH). Using the form of a human heart, we designed a sTAH, which consists of only two ventricles and produced it using a 3D-printing, lost-wax casting technique. The diastolic properties of the sTAH were defined and the performance of the sTAH was evaluated on a hybrid mock circulation under various physiological conditions. The sTAH achieved a blood flow of 2.2 L/min against a systemic vascular resistance of 1.11 mm Hg s/mL (afterload), when operated at 80 bpm. At the same time, the mean pulmonary venous pressure (preload) was fixed at 10 mm Hg. Furthermore, an aortic pulse pressure of 35 mm Hg was measured, with a mean aortic pressure of 48 mm Hg. The sTAH generated physiologically shaped signals of blood flow and pressures by mimicking the movement of a real heart. The preliminary results of this study show a promising potential of the soft pumps in heart replacements. Further work, focused on increasing blood flow and in turn aortic pressure is required.

In Vivo Evaluation of Physiologic Control Algorithms for Left Ventricular Assist Devices Based on Left Ventricular Volume or Pressure

Turbodynamic left ventricular assist devices (LVADs) provide a continuous flow depending on the speed at which the pump is set, and do not adapt to the changing requirements of the patient. The limited adaptation of the pump flow to the amount of venous return can lead to ventricular suction or overload. Physiological control may compensate such situations by an automatic adaptation of the pump flow to the volume status of the left ventricle. We evaluated two physiological control algorithms in an acute study with eight healthy pigs. Both controllers imitate the Frank-Starling law of the heart and are based on a measurement of the left ventricular volume or pressure, respectively. After implantation of a modified Deltastream DP2 blood pump as an LVAD, we tested the responses of the physiological controllers to hemodynamic changes and compared them with the response of the constant speed mode. Both physiological controllers adapted the pump speed such that the flow was more sensitive to preload and less sensitive to afterload, as compared to the constant speed mode. As a result, the risk for suction was strongly reduced. Five suction events were observed in the constant speed mode, one with the volume-based controller, and none with the pressure-based controller. The results suggest that both physiological controllers have the potential to reduce the number of adverse events when used in the clinical setting.Turbodynamic left ventricular assist devices (LVADs) provide a continuous flow depending on the speed at which the pump is set, and do not adapt to the changing requirements of the patient. The limited adaptation of the pump flow (PF) to the amount of venous return can lead to ventricular suction or overload. Physiologic control may compensate such situations by an automatic adaptation of the PF to the volume status of the left ventricle. We evaluated two physiologic control algorithms in an acute study with eight healthy pigs. Both controllers imitate the Frank–Starling law of the heart and are based on a measurement of the left ventricular volume (LVV) or pressure (LVP), respectively. After implantation of a modified Deltastream DP2 blood pump as an LVAD, we tested the responses of the physiologic controllers to hemodynamic changes and compared them with the response of the constant speed (CS) mode. Both physiologic controllers adapted the pump speed (PS) such that the flow was more sensitive to preload and less sensitive to afterload, as compared with the CS mode. As a result, the risk for suction was strongly reduced. Five suction events were observed in the CS mode, one with the volume-based controller and none with the pressure-based controller. The results suggest that both physiologic controllers have the potential to reduce the number of adverse events when used in the clinical setting.

Left Ventricular Assist Devices: Challenges Toward Sustaining Long-Term Patient Care

Over the last few decades, the left ventricular assist device (LVAD) technology has been tremendously improved transitioning from large and noisy paracorporeal volume displacement pumps to small implantable turbodynamic devices with only a single transcutaneous element, the driveline. Nevertheless, there remains a great demand for further improvements to meet the challenge of having a robust and safe device for long-term therapy. Here, we review the state of the art and highlight four key areas of needed improvement targeting long-term, sustainable LVAD function: (1) LVADs available today still have a high risk of thromboembolic and bleeding events that could be addressed by the rational fabrication of novel surface structures and endothelialization approaches aiming at improving the device hemocompatibility. (2) Novel, fluid dynamically optimized pump designs will further reduce blood damage. (3) Infection due to the paracorporeal driveline can be avoided with a transcutaneous energy transmission system that additionally allows for increased freedom of movement. (4) Finally, the lack of pump flow adaptation needs to be encountered with physiological control systems, working collaboratively with biocompatible sensor devices, targeting the adaptation of the LVAD flow to the perfusion requirements of the patient. The interdisciplinary Zurich Heart project investigates these technology gaps paving the way toward LVADs for long-term, sustainable therapy.

The Dilemma of Managing Iterations in Time-to-market Development Processes

This paper considers the authors’ experience in industrial practice and reviews it from the point of view of scientific discussion. From scientific point of view there are three major Research questions: Why are iterations conceived differently? What makes an iteration valuable or harmful? What are appropriate strategies to deal with iterations under time pressure? The Papers give answers on this major research question by showing different aspects of time-to-market development processes and the challenge of effectively handling iterations within them. One of the authors was development head of a business unit responsible for various development and innovation projects. The other, in his position as global process manager for research and development, was responsible for the design and improvement of development processes in the same company. Thus both views represent the conflicting aspect of process modelling and iteration, which is a key topic in scientific discussion

Control of the fluid viscosity in a mock circulation

A mock circulation allows the in vitro investigation, development, and testing of ventricular assist devices. An aqueous-glycerol solution is commonly used to mimic the viscosity of blood. Due to evaporation and temperature changes, the viscosity of the solution drifts from its initial value and therefore, deviates substantially from the targeted viscosity of blood. Additionally, the solution needs to be exchanged to account for changing viscosities when mimicking different hematocrits. This article presents a method to control the viscosity in a mock circulation. This method makes use of the relationship between temperature and viscosity of aqueous-glycerol solutions and employs the automatic control of the viscosity of the fluid. To that end, an existing mock circulation was extended with an industrial viscometer, temperature probes, and a heating nozzle band. The results obtained with different fluid viscosities show that a viscosity controller is vital for repeatable experimental conditions on mock circulations. With a mixture ratio of 49 mass percent of aqueous-glycerol solution, the controller can mimic a viscosity range corresponding to a hematocrit between 29 and 42% in a temperature range of 30-42°C. The control response has no overshoot and the settling time is 8.4 min for a viscosity step of 0.3 cP, equivalent to a hematocrit step of 3.6%. Two rotary blood pumps that are in clinical use are tested at different viscosities. At a flow rate of 5 L/min, both show a deviation of roughly 15 and 10% in motor current for high rotor speeds. The influence of different viscosities on the measured head pressure is negligible. Viscosity control for a mock circulation thus plays an important role for assessing the required motor current of ventricular assist devices. For the investigation of the power consumption of rotary blood pumps and the development of flow estimators where the motor current is a model input, an integrated viscosity controller is a valuable contribution to an accurate testing environment.

Modeling and Performance Evaluation of a Robotic Treatment Couch for Tumor Tracking

Abstract Tumor motion during radiation therapy increases the irradiation of healthy tissue. However, this problem may be mitigated by moving the patient via the treatment couch such that the tumor motion relative to the beam is minimized. The treatment couch poses limitations to the potential mitigation, thus the performance of the Protura (CIVCO) treatment couch was characterized and numerically modeled. The unknown parameters were identified using chirp signals and verified with one-dimensional tumor tracking. The Protura tracked chirp signals well up to 0.2 Hz in both longitudinal and vertical directions. If only the vertical or only the longitudinal direction was tracked, the Protura tracked well up to 0.3 Hz. However, there was unintentional yet substantial lateral motion in the former case. And during vertical motion, the extension caused rotation of the Protura around the lateral axis. The numerical model matched the Protura up to 0.3 Hz. Even though the Protura was designed for static positioning, it was able to reduce the tumor motion by 69% (median). The correlation coefficient between the tumor motion reductions of the Protura and the model was 0.99. Therefore, the model allows tumor-tracking results of the Protura to be predicted.

Investigation of the Axial Gap Clearance in a Hydrodynamic-Passive Magnetically Levitated Rotary Blood Pump Using X-Ray Radiography: AXIAL GAP CLEARANCE IN THE HVAD

The HeartWare HVAD is a radial rotary blood pump with a combination of passive magnetic and hydrodynamic bearings to levitate the impeller. The axial gap size between impeller and housing in this bearing and its sensitivity to speed, flow, and pressure difference is difficult to assess. Shear stresses are exceptionally high in this tiny gap making it important for blood damage and related adverse events. Therefore, the aim of this study was to measure the axial gap clearance in the HVAD at different operating conditions employing radiography. To quantify the gap size in the HVAD, the pump was positioned 30 mm in front of the X-ray source employing a microfocus X-ray tube with an acceleration voltage up to 300 kV. Beams were detected on a flat panel detector (Perkin Elmer XRD 1611-CP3). The pump was connected to a tubing circuit with a throttle to adjust flow (0, 5, 10 L/min) and a water glycerol mixture to set the desired viscosity (1, 4, 8 mPas). Rotational speed was varied between 1800 and 3600 rpm. In this study, for clinically relevant conditions at 5 L/min and 2700 rpm, the axial gap was 22 µm. The gap size increased with rotational speeds dependent on the viscosity (2.8, 6.9, and 9.4 µm/1000 rpm for 1, 4, and 8 mPas, respectively), but was independent from the volume flow and the pressure head at constant speeds. In summary, using X-ray radiographic imaging small gaps in a rotary blood pump during operation can be measured in a nondestructive contact-free way. The axial hydrodynamic bearing gap in the HVAD pump was determined to be in the range of about three times the diameter of a red blood cell. Its dependence on operating volume flow and generated pressure head across the pump is not pronounced.

Virtual surgical planning, flow simulation, and 3-dimensional electrospinning of patient-specific grafts to optimize Fontan hemodynamics

Background: Despite advances in the Fontan procedure, there is an unmet clinical need for patient‐specific graft designs that are optimized for variations in patient anatomy. The objective of this study is to design and produce patient‐specific Fontan geometries, with the goal of improving hepatic flow distribution (HFD) and reducing power loss (Ploss), and manufacturing these designs by electrospinning. Methods: Cardiac magnetic resonance imaging data from patients who previously underwent a Fontan procedure (n = 2) was used to create 3‐dimensional models of their native Fontan geometry using standard image segmentation and geometry reconstruction software. For each patient, alternative designs were explored in silico, including tube‐shaped and bifurcated conduits, and their performance in terms of Ploss and HFD probed by computational fluid dynamic (CFD) simulations. The best‐performing options were then fabricated using electrospinning. Results: CFD simulations showed that the bifurcated conduit improved HFD between the left and right pulmonary arteries, whereas both types of conduits reduced Ploss. In vitro testing with a flow‐loop chamber supported the CFD results. The proposed designs were then successfully electrospun into tissue‐engineered vascular grafts. Conclusions: Our unique virtual cardiac surgery approach has the potential to improve the quality of surgery by manufacturing patient‐specific designs before surgery, that are also optimized with balanced HFD and minimal Ploss, based on refinement of commercially available options for image segmentation, computer‐aided design, and flow simulations.

Automated interpretation of eye–hand coordination in mobile eye tracking recordings

Mobile eye tracking is beneficial for the analysis of human–machine interactions of tangible products, as it tracks the eye movements reliably in natural environments, and it allows for insights into human behaviour and the associated cognitive processes. However, current methods require a manual screening of the video footage, which is time-consuming and subjective. This work aims to automatically detect cognitive demanding phases in mobile eye tracking recordings. The approach presented combines the user’s perception (gaze) and action (hand) to isolate demanding interactions based upon a multi-modal feature level fusion. It was validated in a usability study of a 3D printer with 40 participants by comparing the usability problems found to a thorough manual analysis. The new approach detected 17 out of 19 problems, while the time for manual analyses was reduced by 63%. More than eye tracking alone, adding the information of the hand enriches the insights into human behaviour. The field of AI could significantly advance our approach by improving the hand-tracking through region proposal CNNs, by detecting the parts of a product and mapping the demanding interactions to these parts, or even by a fully automated end-to-end detection of demanding interactions via deep learning. This could set the basis for machines providing real-time assistance to the machine’s users in cases where they are struggling.