First-in-human robotic percutaneous coronary intervention by the ROSES robotic system: a case report.

Background: Robotic-assisted percutaneous coronary intervention (R-PCI) is increasingly gaining acceptance owing to several advantages. Case summary: Here, we report the first-in-human R-PCI performed with RObotic System for Endovascular Surgery (ROSES), an innovative robotic system designed to perform transcatheter angioplasty. We have reported a case of severe proximal posterolateral (PL) branch disease of the right coronary artery managed with R-PCI. Discussion: In this early clinical experience, the use of the ROSES robotic system seems to be safe and effective. However, this report still represents an early feasibility study, and the use of this technology in more challenging anatomies including the presence of severe tortuosity, severe calcification, or interventions requiring multiple wires and balloons needs to be further studied. A larger, prospective, multicentre pivotal clinical trial designed to test the ROSES robotic angioplasty system in a larger number of patients is currently ongoing.

The Twin Forceps: A New Instrument for SILS.

In the last ten years, the single incision laparoscopic surgery (SILS) is gaining more interest than the traditional laparoscopic surgery (LAP). Many studies make a comparison between the performances of the SILS and the LAP. The results show that the single incision laparoscopic surgery reduces pain, length of period of postoperative hospitalization, and loss of blood. This technique is also able to reduce the infection sites. In spite of many advantages, SILS reveals some problems: laparoscopic instruments triangulation and small workspace. The surgeon has to be more skillful to make a surgery in SILS because the surgeon has only three laparoscopic instruments and only one hole in the abdomen cavity. In this paper, a novel laparoscopic instrument to help the surgeon during a SILS operation is presented. This instrument is innovative forceps with double graspers. Different designs of this instrument are presented, with the final one which greatly simplifies both construction and operation. The initial experience in the laboratory with the innovative instrument is presented. The surgeon experienced in laparoscopic surgery and with the help of assistants performed a training program based on predetermined task performed in simulation box (laparoscopic box-trainer).

Left ventricle afterload impedance control by an axial flow ventricular assist device: a potential tool for ventricular recovery.

Ventricular assist devices (VADs) are increasingly used for supporting blood circulation in heart failure patients. To protect or even to restore the myocardial function, a defined loading of the ventricle for training would be important. Therefore, a VAD control strategy was developed that provides an explicitly definable loading condition for the failing ventricle. A mathematical model of the cardiovascular system with an axial flow VAD was used to test the control strategy in the presence of a failing left ventricle, slight physical activity, and a recovering scenario. Furthermore, the proposed control strategy was compared to a conventional constant speed mode during hemodynamic changes (reduced venous return and arterial vasoconstriction). The physiological benefit of the control strategy was manifested by a large increase in the ventricular Frank-Starling reserve and by restoration of normal hemodynamics (5.1 L/min cardiac output at a left atrial pressure of 10 mmHg vs. 4.2 L/min at 21 mmHg in the unassisted case). The control strategy automatically reduced the pump speed in response to reduced venous return and kept the pump flow independent of the vasoconstriction condition. Most importantly, the ventricular load was kept stable within 1%, compared to a change of 75% for the constant speed. As a key feature, the proposed control strategy provides a defined and adjustable load to the failing ventricle by an automatic regulation of the VAD speed and allows a controlled training of the myocardium. This, in turn, may represent a potential additional tool to increase the number of patients showing recovery.

Dynamic modeling and identification of an axial flow ventricular assist device.

An accurate characterization of the hemodynamic behavior of ventricular assist devices (VADs) is of paramount importance for proper modeling of the heart-pump interaction and the validation of control strategies. This paper describes an advanced test bench, which is able to generate complex hydraulic loads, and a procedure to characterize rotary blood pump performance in a pulsatile environment. Special focus was laid on model parameter identifiability in the frequency domain and the correlation between dynamic and steady-state models. Twelve combinations of different flow/head/speed signals, which covered the clinical VAD working conditions, were generated for the pump characterization. Root mean square error (RMSE) between predicted and measured flow was used to evaluate the VAD model. The found parameters were then validated with broadband random signals. In the experiments the optimization process always successfully converged. Even in the most demanding dynamic conditions the RMSE was 7.4 ml/sec and the absolute error never exceeded 24.9 ml/sec. Validity ranges for the identified VAD model were: flow 0-180 ml/sec; head 0-120 mmHg; speed 7.5-12.5 krpm. In conclusion, a universal test bench and a characterization procedure to describe the hydrodynamic properties of rotary blood pumps were established. For a particular pump, a reliable mathematical model was identified that correctly reproduced the relationship between instantaneous VAD flow, head and impeller speed.

A modified elastance model to control mock ventricles in real-time: numerical and experimental validation.

This article describes an elastance-based mock ventricle able to reproduce the correct ventricular pressure-volume relationship and its correct interaction with the hydraulic circuit connected to it. A real-time control of the mock ventricle was obtained by a new left ventricular mathematical model including resistive and inductive terms added to the classical Suga-Sagawa elastance model throughout the whole cardiac cycle. A valved piston pump was used to mimic the left ventricle. The pressure measured into the pump chamber was fed back into the mathematical model and the calculated reference left ventricular volume was used to drive the piston. Results show that the classical model is very sensitive to pressure disturbances, especially during the filling phase, while the modified model is able to filter out the oscillations thus eliminating their detrimental effects. The presented model is thus suitable to control mock ventricles in real-time, where sudden pressure disturbances represent a key issue and are not negligible. This real-time controlled mock ventricle is able to reproduce the elastance mechanism of a natural ventricle by mimicking its preload (mean atrial pressure) and afterload (mean aortic pressure) sensitivity, i.e., the Starling law. Therefore, it can be used for designing and testing cardiovascular prostheses due to its capability to reproduce the correct ventricle-vascular system interaction.

Pressure pulsation in roller pumps: a validated lumped parameter model.

During open-heart surgery roller pumps are often used to keep the circulation of blood through the patient body. They present numerous key features, but they suffer from several limitations: (a) they normally deliver uncontrolled pulsatile inlet and outlet pressure; (b) blood damage appears to be more than that encountered with centrifugal pumps. A lumped parameter mathematical model of a roller pump (Sarns 7000, Terumo CVS, Ann Arbor, MI, USA) was developed to dynamically simulate pressures at the pump inlet and outlet in order to clarify the uncontrolled pulsation mechanism. Inlet and outlet pressures obtained by the mathematical model have been compared with those measured in various operating conditions: different rollers' rotating speed, different tube occlusion rates, and different clamping degree at the pump inlet and outlet. Model results agree with measured pressure waveforms, whose oscillations are generated by the tube compression/release mechanism during the rollers' engaging and disengaging phases. Average Euclidean Error (AEE) was 20mmHg and 33mmHg for inlet and outlet pressure estimates, respectively. The normalized AEE never exceeded 0.16. The developed model can be exploited for designing roller pumps with improved performances aimed at reducing the undesired pressure pulsation.

Left ventricle load impedance control by apical VAD can help heart recovery and patient perfusion: a numerical study.

The aim of this work is to investigate the dependence between left ventricular load impedance control by an apical ventricular assist device (VAD) and the consequent benefits for pathological heart recovery. A pathological left ventricle with 34% contractility has been simulated in the assisted and nonassisted conditions. By means of an extended Kalman filter, left ventricular pressure-volume loops have been partially estimated and ventricular as well as circulatory quantities inferred. The heart operation mode, based on cardiac energetic criteria, is imposed by controlling the VAD filling phase. In the assisted condition, results show that the left ventricle end-diastolic volume, left atrial pressure, and wall stress all decrease; stroke volume, ejection fraction, ventricular efficiency, aortic pressure, and cardiac output all increase. Benefits are also evident for the right ventricle and systemic and pulmonary circulation. The strategy outlined in this work also shows that good results for heart recovery are achievable and a possible way to improve the functional properties of commercial pulsatile VADs.

Validation of a calibration technique for 6-DOF instrumented spatial linkages.

This paper presents a practical and effective approach to the calibration of instrumented spatial linkages for biomechanical applications. A 6-DOF mechanical linkage with rotational transducers is designed and in-house manufactured for this purpose. In order to assess the validity of the proposed calibration technique and to distinguish between geometrical and electrical parameters uncertainties, high-precision optical encoders are used and calibration is addressed from a kinematic point of view only. The proposed technique is based on a closed-loop method, in which the end segments of the linkage are connected to each other by revolute joints. A parametrical model of the system is formulated using a standard link-to-link transformation matrices approach. Continuous data collection is carried out and a recursive identification of kinematic parameters is implemented by the use of an extended Kalman filter algorithm. Results shows that the proposed technique, despites its simplicity, is effective in improving the accuracy of the system up to its theoretically computed resolution, which limits the performance of the real system.