Medical Microrobots.

Scientists around the world have long aimed to produce miniature robots that can be controlled inside the human body to aid doctors in identifying and treating diseases. Such microrobots hold the potential to access hard-to-reach areas of the body through the natural lumina. Wireless access has the potential to overcome drawbacks of systemic therapy, as well as to enable completely new minimally invasive procedures. The aim of this review is fourfold: first, to provide a collection of valuable anatomical and physiological information on the target working environments together with engineering tools for the design of medical microrobots; second, to provide a comprehensive updated survey of the technological state of the art in relevant classes of medical microrobots; third, to analyze currently available tracking and closed-loop control strategies compatible with the in-body environment; and fourth, to explore the challenges still in place, to steer and inspire future research.

Neonatal intubation: what are we doing?

How and when the forces are applied during neonatal intubation are currently unknown. This study investigated the pattern of the applied forces by using sensorized laryngoscopes during the intubation process in a neonatal manikin. Nine users of direct laryngoscope and nine users of straight-blade video laryngoscope were included in a neonatal manikin study. During each procedure, relevant forces were measured using a force epiglottis sensor that was placed on the distal surface of the blade. The pattern of the applied forces could be divided into three sections. With the direct laryngoscope, the first section showed either a quick rise of the force or a discontinuous rise with several peaks; after reaching the maximum force, there was a sort of plateau followed by a quick drop of the applied forces. With the video laryngoscope, the first section showed a quick rise of the force; after reaching the maximum force, there was an irregular and heterogeneous plateau, followed by heterogeneous decreases of the applied forces. Moreover, less forces were recorded when using the video laryngoscope.    Conclusions: This neonatal manikin study identified three sections in the diagram of the forces applied during intubation, which likely mirrored the three main phases of intubation. Overall, the pattern of each section showed some differences in relation to the laryngoscope (direct or video) that was used during the procedure. These findings may provide useful insights for improving the understanding of the procedure. What is Known: • Neonatal intubation is a life-saving procedure that requires a skilled operator and may cause direct trauma to the tissues and precipitate adverse reactions. • Intubation with a videolaryngoscope requires less force than with a direct laryngoscope, but how and when the forces are applied during the whole neonatal intubation procedure are currently unknown. What is New: • Forces applied to the epiglottis during intubation can be divided into three sections: (i) an initial increase, (ii) a sort of plateau, and (iii) a decrease. • The pattern of each section shows some differences in relation to the laryngoscope (direct or videolaryngoscope) that is used during the procedure.

Applied forces with direct versus indirect laryngoscopy in neonatal intubation: a randomized crossover mannequin study.

PURPOSE: In adult mannequins, videolaryngoscopy improves glottic visualization with lower force applied to upper airway tissues and reduced task workload compared with direct laryngoscopy. This trial compared oropharyngeal applied forces and subjective workload during direct vs indirect (video) laryngoscopy in a neonatal mannequin. METHODS: We conducted a randomized crossover trial of intubation with direct laryngoscopy, straight blade videolaryngoscopy, and hyperangulated videolaryngoscopy in a neonatal mannequin. Thirty neonatal/pediatric/anesthesiology consultants and residents participated. The primary outcome measure was the maximum peak force applied during intubation. Secondary outcome measures included the average peak force applied during intubation, time needed to intubate, and subjective workload. RESULTS: Direct laryngoscopy median forces on the epiglottis were 8.2 N maximum peak and 6.8 N average peak. Straight blade videolaryngoscopy median forces were 4.7 N maximum peak and 3.6 N average peak. Hyperangulated videolaryngoscopy median forces were 2.8 N maximum peak and 2.1 N average peak. The differences were significant between direct laryngoscopy and straight blade videolaryngoscopy, and between direct laryngoscopy and hyperangulated videolaryngoscopy. Significant differences were also found in the top 10th percentile forces on the epiglottis and palate, but not in the median forces on the palate. Time to intubation and subjective workload were comparable with videolaryngoscopy vs direct laryngoscopy. CONCLUSIONS: The lower force applied during videolaryngoscopy in a neonatal mannequin model suggests a possible benefit in reducing potential patient harm during intubation, but the clinical implications require assessment in future studies. REGISTRATION: ClinicalTrials.gov (NCT05197868); registered 20 January 2022.

RéSUMé: OBJECTIF: Sur les mannequins adultes, la vidéolaryngoscopie améliore la visualisation glottique avec une force plus faible appliquée aux tissus des voies aériennes supérieures et une charge de travail réduite par rapport à la laryngoscopie directe. Cette étude a comparé les forces appliquées sur la zone oropharyngée et la charge de travail subjective au cours d'une laryngoscopie directe vs indirecte (vidéolaryngoscopie) sur un mannequin néonatal. MéTHODE: Nous avons réalisé une étude randomisée croisée d'intubation par laryngoscopie directe, vidéolaryngoscopie à lame droite et vidéolaryngoscopie avec lame hyperangulée sur un mannequin néonatal. Trente spécialistes diplômés et résidents en néonatologie, en pédiatrie et en anesthésiologie y ont participé. Le critère d'évaluation principal était le pic de force maximal obtenu pendant l'intubation. Les critères d'évaluation secondaires comprenaient la force maximale moyenne appliquée pendant l'intubation, le temps nécessaire pour intuber et la charge de travail subjective. RéSULTATS: Les forces médianes appliquées sur l'épiglotte lors de la laryngoscopie directe étaient de 8,2 N pour le pic maximum et de 6,8 N pour le pic moyen. Les forces médianes appliquées lors de la vidéolaryngoscopie à lame droite étaient de 4,7 N pour le pic maximum et de 3,6 N pour le pic moyen. Les forces médianes appliquées lors de la vidéolaryngoscopie avec lame hyperangulée étaient de 2,8 N pour le pic maximum et de 2,1 N pour le pic moyen. Les différences étaient significatives entre la laryngoscopie directe et la vidéolaryngoscopie à lame droite, et entre la laryngoscopie directe et la vidéolaryngoscopie avec lame hyperangulée. Des différences significatives ont également été observées dans le 10e percentile supérieur des forces sur l'épiglotte et le palais, mais pas dans les forces médianes sur le palais. Le délai d'intubation et la charge de travail subjective étaient comparables entre la vidéolaryngoscopie et la laryngoscopie directe. CONCLUSION: La force plus faible appliquée lors de la vidéolaryngoscopie dans un modèle de mannequin néonatal suggère un avantage possible de réduction des lésions potentielles pour le patient pendant l'intubation, mais les implications cliniques doivent être évaluées dans des études futures. ENREGISTREMENT DE L'éTUDE: ClinicalTrials.gov (NCT05197868); enregistré le 20 janvier 2022.

Spherical Wrist Manipulator Local Planner for Redundant Tasks in Collaborative Environments.

Standard industrial robotic manipulators use well-established high performing technologies. However, such manipulators do not guarantee a safe Human-Robot Interaction (HRI), limiting their usage in industrial and medical applications. This paper proposes a novel local path planner for spherical wrist manipulators to control the execution of tasks where the manipulator number of joints is redundant. Such redundancy is used to optimize robot motion and dexterity. We present an intuitive parametrization of the end-effector (EE) angular motion, which decouples the rotation of the third joint of the wrist from the rest of the angular motions. Manipulator EE motion is controlled through a decentralized linear system with closed-loop architecture. The local planner integrates a novel collision avoidance strategy based on a potential repulsive vector applied to the EE. Contrary to classic potential field approaches, the collision avoidance algorithm considers the entire manipulator surface, enhancing human safety. The local path planner is simulated in three generic scenarios: (i) following a periodic reference, (ii) a random sequence of step signal references, and (iii) avoiding instantly introduced obstacles. Time and frequency domain analysis demonstrated that the developed planner, aside from better parametrizing redundant tasks, is capable of successfully executing the simulated paths (max error = 0.25°) and avoiding obstacles.

Semiautonomous Robotic Manipulator for Minimally Invasive Aortic Valve Replacement.

Aortic valve surgery is the preferred procedure for replacing a damaged valve with an artificial one. The ValveTech robotic platform comprises a flexible articulated manipulator and surgical interface supporting the effective delivery of an artificial valve by teleoperation and endoscopic vision. This article presents our recent work on force-perceptive, safe, semiautonomous navigation of the ValveTech platform prior to valve implantation. First, we present a force observer that transfers forces from the manipulator body and tip to a haptic interface. Second, we demonstrate how hybrid forward/inverse mechanics, together with endoscopic visual servoing, lead to autonomous valve positioning. Benchtop experiments and an artificial phantom quantify the performance of the developed robot controller and navigator. Valves can be autonomously delivered with a 2.0±0.5 mm position error and a minimal misalignment of 3.4±0.9°. The hybrid force/shape observer (FSO) algorithm was able to predict distributed external forces on the articulated manipulator body with an average error of 0.09 N. FSO can also estimate loads on the tip with an average accuracy of 3.3%. The presented system can lead to better patient care, delivery outcome, and surgeon comfort during aortic valve surgery, without requiring sensorization of the robot tip, and therefore obviating miniaturization constraints.

Erythro-Magneto-HA-Virosome: A Bio-Inspired Drug Delivery System for Active Targeting of Drugs in the Lungs.

Over the past few decades, finding more efficient and selective administration routes has gained significant attention due to its crucial role in the bioavailability, absorption rate and pharmacokinetics of therapeutic substances. The pulmonary delivery of drugs has become an attractive target of scientific and biomedical interest in the health care research area, as the lung, thanks to its high permeability and large absorptive surface area and good blood supply, is capable of absorbing pharmaceuticals either for local deposition or for systemic delivery. Nevertheless, the pulmonary drug delivery is relatively complex, and strategies to mitigate the effects of mechanical, chemical and immunological barriers are required. Herein, engineered erythrocytes, the Erythro-Magneto-Hemagglutinin (HA)-virosomes (EMHVs), are used as a novel strategy for efficiently delivering drugs to the lungs. EMHV bio-based carriers exploit the physical properties of magnetic nanoparticles to achieve effective targeting after their intravenous injection thanks to an external magnetic field. In addition, the presence of hemagglutinin fusion proteins on EMHVs' membrane allows the DDS to anchor and fuse with the target tissue and locally release the therapeutic compound. Our results on the biomechanical and biophysical properties of EMHVs, such as the membrane robustness and deformability and the high magnetic susceptibility, as well as their in vivo biodistribution, highlight that this bio-inspired DDS is a promising platform for the controlled and lung-targeting delivery of drugs, and represents a valuable alternative to inhalation therapy to fulfill unmet clinical needs.

A novel microwave tool for robotic liver resection in minimally invasive surgery.

INTRODUCTION: During the last two decades, many surgical procedures have evolved from open surgery to minimally invasive surgery (MIS). This limited invasiveness has motivated the development of robotic assistance platforms to obtain better surgical outcomes. Nowadays, the da Vinci robot is a commercial tele-robotic platform widely used for different surgical applications. MATERIAL AND METHODS: In this work, the da Vinci Research Kit (dVRK), namely the research version of the da Vinci, is used to manipulate a novel microwave device in a teleoperation scenario. The dVRK provides an open source platform, so that the novel microwave tool, dedicated to prevention bleeding during hepatic resection surgery, is mechanically integrated on the slave side, while the software interface is adapted in order to correctly control tool pose. Tool integration is validated through in-vitro and ex-vivo tests performed by expert surgeons, meanwhile the coagulative efficacy of the developed tool in a perfused liver model was proved in in-vivo tests. RESULTS AND CONCLUSIONS: An innovative microwave tool for liver robotic resection has been realized and integrated into a surgical robot. The tool can be easily operated through the dVRK without limiting the intuitive and friendly use, and thus easily reaching the hemostasis of vessels.

A personalised prosthetic liner with embedded sensor technology: a case study.

BACKGROUND: Numerous sensing techniques have been investigated in an effort to monitor the main parameters influencing the residual limb/prosthesis interface, fundamental to the optimum design of prosthetic socket solutions. Sensing integration within sockets is notoriously complex and can cause user discomfort. A personalised prosthetic liner with embedded sensors could offer a solution. However, to allow for a functional and comfortable instrumented liner, highly customised designs are needed. The aim of this paper is to presents a novel approach to manufacture fully personalised liners using scanned three-dimensional image data of the patient's residual limb, combined with designs that allow for sensor integration. To demonstrate the feasibility of the proposed approach, a personalised liner with embedded temperature and humidity sensors was realised and tested on a transtibial amputee, presented here as a case study. METHODS: The residual limb of a below knee amputee was first scanned and a three-dimensional digital image created. The output was used to produce a personalised prosthesis. The liner was manufactured using a cryogenic Computer Numeric Control (CNC) machining approach. This method enables fast, direct and precise manufacture of soft elastomer products. Twelve Hygrochron Data Loggers, able to measure both temperature and humidity, were embedded in specific liner locations, ensuring direct sensor-skin contact. The sensor locations were machined directly into the liner, during the manufacturing process. The sensors outputs were assessed on the below amputee who took part in the study, during resting (50 min) and walking activities (30 min). To better describe the relative thermal properties of new liner, the same tests were repeated with the amputee wearing his existing liner. Quantitative comparisons of the thermal properties of the new liner solution with that currently used in clinical practice are, therefore, reported. RESULTS: The liner machining process took approximately 4 h. Fifteen minutes after donning the prosthesis, the skin temperature reached a plateau. Physical activity rapidly increased residuum skin temperatures, while cessation of activity caused a moderate decrease. Humidity increased throughout the observation period. In addition, the new liner showed better thermal properties with respect to the current liner solution (4% reduction in skin temperature). CONCLUSIONS: This work describes a personalised liner solution, with embedded temperature and humidity sensors, developed through an innovative approach. This new method allows for a range of sensors to be smoothly embedded into a liner, which is capable of measuring changes in intra-socket microclimate conditions, resulting in the design of advanced socket solutions personalised specifically for individual requirements. In future, this method will not only provide a personalised liner but will also enable dynamic assessment of how a residual limb behaves within the socket during daily activities.

Selective perfusion of coronary vasculature in preterm sheep: a methodological innovation undermined by unfavourable operation of the foramen ovale.

Antenatal cardiac intervention affords new prospects for hypoplastic left heart syndrome. Its success, however, may come not only from absence of impediments to blood flow but also from a sufficiently developed cardiac wall. Here, we examined the feasibility to perfuse selectively the fetal coronary circulation for treatment with growth promoting agents. Pregnant sheep (94-114 days gestation, term 145 days) were used. An aortic stop-flow procedure was developed for intracoronary access in the nonexposed fetus and human mesenchymal stem cells and their exosomes served as test agents. We found that aortic stop-flow ensures preferential distribution of fluorescent microspheres to the heart. However, intracoronary administration of stem cells or exosomes was detrimental, with fetal demise occurring around surgery or at variable intervals afterwards. Coincidentally, stop-flow caused by itself a marked rise of intraluminal pressure within the occluded aorta along with histological signs of coronary obstruction. We conclude that it is feasible to perfuse selectively the coronary circulation of the preterm fetus, but treatments are not compatible with survival of the animals. The cause for failure is found in the absence of hemodynamic compensation to stop-flow via a left-to-right shunt. This unexpected event is attributed to a largely membranous foramen ovale, characteristic of sheep, that collapses under pressure.

Comparative analysis of occlusion methods for artificial sphincters.

An artificial sphincter is a device that replaces the function of the biological sphincter by occluding the relative biological lumen. The investigation of occlusion methods for artificial sphincters is crucial for a reliable and effective design of such devices. The compression induced onto the tissue by a certain pressure depends on the biomechanical and physiological features of the lumen and on the specific occlusion method. A numerical model and an experimental evaluation are presented here to assess the efficiency of different occlusion methods. Numerical models of circumferential occlusion and clamping occlusion methods to simulate the compression of the biological lumen were developed. Results revealed a relationship between the efficiency of the occlusion method and the physiological condition of the lumen. With differences related to the testing setup, this relationship was also confirmed experimentally by conducting tests on biological simulators. We analyzed the occlusion method to adopt as the physiological pressure (ie, leakage pressure values) changed. In particular, we focused on the urinary incontinence, which is a dysfunction involving the external sphincter surrounding the urethra. In this scenario, we demonstrated that a clamping occlusion is an efficient method to compress the urethra, whose physiological pressures range between 4 and 12 kPa. The clamping occlusion method resulted up to 35% more efficient in terms of sealing pressure than the circumferential one for a closing pressure varying between 2.3 and 11.5 kPa.

An Improved Strategy for Detection and Localization of Nodules in Liver Tissues by a 16 MHz Needle Ultrasonic Probe Mounted on a Robotic Platform.

This study presents an improved strategy for the detection and localization of small size nodules (down to few mm) of agar in excised pork liver tissues via pulse-echo ultrasound measurements performed with a 16 MHz needle probe. This work contributes to the development of a new generation of medical instruments to support robotic surgery decision processes that need information about cancerous tissues in a short time (minutes). The developed ultrasonic probe is part of a scanning platform designed for the automation of surgery-associated histological analyses. It was coupled with a force sensor to control the indentation of tissue samples placed on a steel plate. For the detection of nodules, we took advantage of the property of nodules of altering not only the acoustical properties of tissues producing ultrasound attenuation, but also of developing patterns at their boundary that can modify the shape and the amplitude of the received echo signals from the steel plate supporting the tissues. Besides the Correlation Index Amplitude (CIA), which is linked to the overall amplitude changes of the ultrasonic signals, we introduced the Correlation Index Shape (CIS) linked to their shape changes. Furthermore, we applied AND-OR logical operators to these correlation indices. The results were found particularly helpful in the localization of the irregular masses of agar we inserted into some excised liver tissues, and in the individuation of the regions of major interest over which perform the vertical dissections of tissues in an automated analysis finalized to histopathology. We correctly identified up to 89% of inclusions, with an improvement of about 14% with respect to the result obtained (78%) from the analysis performed with the CIA parameter only.

High-Resolution SPECT Imaging of Stimuli-Responsive Soft Microrobots.

Untethered small-scale robots have great potential for biomedical applications. However, critical barriers to effective translation of these miniaturized machines into clinical practice exist. High resolution tracking and imaging in vivo is one of the barriers that limit the use of micro- and nanorobots in clinical applications. Here, the inclusion of radioactive compounds in soft thermoresponsive magnetic microrobots is investigated to enable their single-photon emission computed tomography imaging. Four microrobotic platforms differing in hydrogel structure and four 99m Tc[Tc]-based radioactive compounds are investigated in order to achieve optimal contrast agent retention and optimal imaging. Single microrobot imaging of structures as low as 100 µm in diameter, as well as tracking of shape switching from tubular to planar configurations by inclusion of 99m Tc[Tc] colloid in the hydrogel structure, is reported.

Soft Hydrogel Zwitterionic Coatings Minimize Fibroblast and Macrophage Adhesion on Polyimide Substrates.

Minimizing the foreign body reaction to polyimide-based implanted devices plays a pivotal role in several biomedical applications. In this work, we propose materials exhibiting nonbiofouling properties and a Young's modulus reflecting that of soft human tissues. We describe the synthesis, characterization, and in vitro validation of poly(carboxybetaine) hydrogel coatings covalently attached to polyimide substrates via a photolabile 4-azidophenyl group, incorporated in poly(carboxybetaine) chains at two concentrations of 1.6 and 3.1 mol %. The presence of coatings was confirmed by attenuated total reflectance Fourier transform infrared spectroscopy. White light interferometry was used to evaluate the coating continuity and thickness (between 3 and 6 µm under dry conditions). Confocal laser scanning microscopy allowed us to quantify the thickness of the swollen hydrogel coatings that ranged between 13 and 32 µm. The different hydrogel formulations resulted in stiffness values ranging from 2 to 19 kPa and led to different fibroblast and macrophage responses in vitro. Both cell types showed a minimum adhesion on the softest hydrogel type. In addition, both the overall macrophage activation and cytotoxicity were observed to be negligible for all of the tested material formulations. These results are a promising starting point toward future advanced implantable systems. In particular, such technology paves the way for novel neural interfaces able to minimize the fibrotic reaction, once implanted in vivo, and to maximize their long-term stability and functionality.

Haptic Glove and Platform with Gestural Control For Neuromorphic Tactile Sensory Feedback In Medical Telepresence †.

Advancements in the study of the human sense of touch are fueling the field of haptics. This is paving the way for augmenting sensory perception during object palpation in tele-surgery and reproducing the sensed information through tactile feedback. Here, we present a novel tele-palpation apparatus that enables the user to detect nodules with various distinct stiffness buried in an ad-hoc polymeric phantom. The contact force measured by the platform was encoded using a neuromorphic model and reproduced on the index fingertip of a remote user through a haptic glove embedding a piezoelectric disk. We assessed the effectiveness of this feedback in allowing nodule identification under two experimental conditions of real-time telepresence: In Line of Sight (ILS), where the platform was placed in the visible range of a user; and the more demanding Not In Line of Sight (NILS), with the platform and the user being 50 km apart. We found that the entailed percentage of identification was higher for stiffer inclusions with respect to the softer ones (average of 74% within the duration of the task), in both telepresence conditions evaluated. These promising results call for further exploration of tactile augmentation technology for telepresence in medical interventions.

A Mechatronic Platform for Computer Aided Detection of Nodules in Anatomopathological Analyses via Stiffness and Ultrasound Measurements.

This study presents a platform for ex-vivo detection of cancer nodules, addressing automation of medical diagnoses in surgery and associated histological analyses. The proposed approach takes advantage of the property of cancer to alter the mechanical and acoustical properties of tissues, because of changes in stiffness and density. A force sensor and an ultrasound probe were combined to detect such alterations during force-regulated indentations. To explore the specimens, regardless of their orientation and shape, a scanned area of the test sample was defined using shape recognition applying optical background subtraction to the images captured by a camera. The motorized platform was validated using seven phantom tissues, simulating the mechanical and acoustical properties of ex-vivo diseased tissues, including stiffer nodules that can be encountered in pathological conditions during histological analyses. Results demonstrated the platform's ability to automatically explore and identify the inclusions in the phantom. Overall, the system was able to correctly identify up to 90.3% of the inclusions by means of stiffness in combination with ultrasound measurements, paving pathways towards robotic palpation during intraoperative examinations.

Artificial Sphincters to Manage Urinary Incontinence: A Review.

Urinary incontinence affects more than 300 million people worldwide. The implantation of a medical device called an artificial urinary sphincter (AUS) is the gold standard treatment when conservative and minimally invasive therapies fail. In this article, the AUSs (extra-urethral and endo-urethral sphincters) available on the market, both presented at the research level and filed as patents, are reviewed. The ability of the different solutions to effectively replace the natural sphincter are discussed, together with advantages and some possible side effects, such as tissue atrophy, overall invasiveness of the implant, and so forth. Finally, future research priorities are discussed for both endo-urethral and extra-urethral approaches considering key engineering aspects, such as materials, compression and closure mechanisms, and implantation methods, with the long-term aim of developing an effective, reliable, durable, and minimally invasive AUS capable of restoring a normal quality of life for incontinent patients.

Neuromorphic Vibrotactile Stimulation of Fingertips for Encoding Object Stiffness in Telepresence Sensory Substitution and Augmentation Applications.

We present a tactile telepresence system for real-time transmission of information about object stiffness to the human fingertips. Experimental tests were performed across two laboratories (Italy and Ireland). In the Italian laboratory, a mechatronic sensing platform indented different rubber samples. Information about rubber stiffness was converted into on-off events using a neuronal spiking model and sent to a vibrotactile glove in the Irish laboratory. Participants discriminated the variation of the stiffness of stimuli according to a two-alternative forced choice protocol. Stiffness discrimination was based on the variation of the temporal pattern of spikes generated during the indentation of the rubber samples. The results suggest that vibrotactile stimulation can effectively simulate surface stiffness when using neuronal spiking models to trigger vibrations in the haptic interface. Specifically, fractional variations of stiffness down to 0.67 were significantly discriminated with the developed neuromorphic haptic interface. This is a performance comparable, though slightly worse, to the threshold obtained in a benchmark experiment evaluating the same set of stimuli naturally with the own hand. Our paper presents a bioinspired method for delivering sensory feedback about object properties to human skin based on contingency-mimetic neuronal models, and can be useful for the design of high performance haptic devices.

Soft Robotic Manipulator for Improving Dexterity in Minimally Invasive Surgery.

BACKGROUND: Combining the strengths of surgical robotics and minimally invasive surgery (MIS) holds the potential to revolutionize surgical interventions. The MIS advantages for the patients are obvious, but the use of instrumentation suitable for MIS often translates in limiting the surgeon capabilities (eg, reduction of dexterity and maneuverability and demanding navigation around organs). To overcome these shortcomings, the application of soft robotics technologies and approaches can be beneficial. The use of devices based on soft materials is already demonstrating several advantages in all the exploitation areas where dexterity and safe interaction are needed. In this article, the authors demonstrate that soft robotics can be synergistically used with traditional rigid tools to improve the robotic system capabilities and without affecting the usability of the robotic platform. MATERIALS AND METHODS: A bioinspired soft manipulator equipped with a miniaturized camera has been integrated with the Endoscopic Camera Manipulator arm of the da Vinci Research Kit both from hardware and software viewpoints. Usability of the integrated system has been evaluated with nonexpert users through a standard protocol to highlight difficulties in controlling the soft manipulator. RESULTS AND CONCLUSION: This is the first time that an endoscopic tool based on soft materials has been integrated into a surgical robot. The soft endoscopic camera can be easily operated through the da Vinci Research Kit master console, thus increasing the workspace and the dexterity, and without limiting intuitive and friendly use.

Total mesorectal excision using a soft and flexible robotic arm: a feasibility study in cadaver models.

BACKGROUND: Sponsored by the European Commission, the FP7 STIFF-FLOP project aimed at developing a STIFFness controllable Flexible and Learn-able manipulator for surgical operations, in order to overcome the current limitations of rigid-link robotic technology. Herein, we describe the first cadaveric series of total mesorectal excision (TME) using a soft and flexible robotic arm for optic vision in a cadaver model. METHODS: TME assisted by the STIFF-FLOP robotic optics was successfully performed in two embalmed male human cadavers. The soft and flexible optic prototype consisted of two modules, each measuring 60 mm in length and 14.3 mm in maximum outer diameter. The robot was attached to a rigid shaft connected to an anthropomorphic manipulator robot arm with six degrees of freedom. The controller device was equipped with two joysticks. The cadavers (BMI 25 and 28 kg/m2) were prepared according to the Thiel embalming method. The procedure was performed using three standard laparoscopic instruments for traction and dissection, with the aid of a 30° rigid optics in the rear for documentation. RESULTS: Following mobilization of the left colonic flexure and division of the inferior mesenteric vessels, TME was completed down to the pelvic floor. The STIFF-FLOP robotic optic arm seemed to acquire superior angles of vision of the surgical field in the pelvis, resulting in an intact mesorectum in both cases. Completion times of the procedures were 165 and 145 min, respectively. No intraoperative complications occurred. No technical failures were registered. CONCLUSIONS: The STIFF-FLOP soft and flexible robotic optic arm proved effective in assisting a laparoscopic TME in human cadavers, with a superior field of vision compared to the standard laparoscopic vision, especially low in the pelvis. The introduction of soft and flexible robotic devices may aid in overcoming the technical challenges of difficult laparoscopic procedures based on standard rigid instruments.