Reducing retraction forces with tactile feedback during robotic total mesorectal excision in a porcine model.

Excessive tissue-instrument interaction forces during robotic surgery have the potential for causing iatrogenic tissue damages. The current in vivo study seeks to assess whether tactile feedback could reduce intraoperative tissue-instrument interaction forces during robotic-assisted total mesorectal excision. Five subjects, including three experts and two novices, used the da Vinci robot to perform total mesorectum excision in four pigs. The grip force in the left arm, used for retraction, and the pushing force in the right arm, used for blunt pelvic dissection around the rectum, were recorded. Tissue-instrument interaction forces were compared between trials done with and without tactile feedback. The mean force exerted on the tissue was consistently higher in the retracting arm than the dissecting arm (3.72 ± 1.19 vs 0.32 ± 0.36 N, p < 0.01). Tactile feedback brought about significant reductions in average retraction forces (3.69 ± 1.08 N vs 4.16 ± 1.12 N, p = 0.02), but dissection forces appeared unaffected (0.43 ± 0.42 vs 0.37 ± 0.28 N, p = 0.71). No significant differences were found between retraction and dissection forces exerted by novice and expert robotic surgeons. This in vivo animal study demonstrated the efficacy of tactile feedback in reducing retraction forces during total mesorectal excision. Further research is required to quantify the clinical impact of such force reduction.

Bio-Inspired Haptic Feedback for Artificial Palpation in Robotic Surgery.

Adding haptic feedback has been reported to improve the outcome of minimally invasive robotic surgery. In this study, we seek to determine whether an algorithm based on simulating responses of a cutaneous afferent population can be implemented to improve the performance of presenting haptic feedback for robot-assisted surgery. We propose a bio-inspired controlling model to present vibration and force feedback to help surgeons localize underlying structures in phantom tissue. A single pair of actuators was controlled by outputs of a model of a population of cutaneous afferents based on the pressure signal from a single sensor embedded in surgical forceps. We recruited 25 subjects including 10 expert surgeons to evaluate the performance of the bio-inspired controlling model in an artificial palpation task using the da Vinci surgical robot. Among the control methods tested, the bio-inspired system was unique in allowing both novices and experts to easily identify the locations of all classes of tumors and did so with reduced contact force and tumor contact time. This work demonstrates the utility of our bio-inspired multi-modal feedback system, which resulted in superior performance for both novice and professional users, in comparison to a traditional linear and the existing piecewise discrete algorithms of haptic feedback.

Transoral Robotic Surgical Proficiency Via Real-Time Tactile Collision Awareness System.

OBJECTIVES: In 2009, the Food and Drug Administration approved the use of the surgical robotic system for removal of benign and malignant conditions of the upper aerodigestive tract. This novel application of robotic-assisted surgery, termed transoral robotic surgery (TORS), places robotic instruments and camera system through the mouth to reach recessed areas of the pharynx and larynx. Over the successive decade, there was a rapid adoption of TORS with a surgical growth rate that continues to increase. Despite the rapid clinical acceptance, the field of TORS has not yet seen substantive changes or advances in the technical shortcomings, the lack of which has restricted objective TORS-specific surgical skills assessment as well as subsequent skills improvement efforts. One of the primary technical challenges of TORS is operating in a confined space, where the robotic system is maneuvered within the restrictive boundaries of the mouth and throat. Due to these confined boundaries of the pharynx, instruments can frequently collide with anatomic structures such as teeth and bone, producing anatomic collisions. Therefore, we hypothesized that anatomic collisions negatively impact TORS surgical performance. Secondarily, we hypothesized that avoidance of unwanted anatomic collisions could improve TORS surgical proficiency. METHODS: Design and fidelity testing for a custom TORS training platform with an integrated anatomic collision-sensing system providing real-time tactile feedback is described. Following successful platform assembly and testing, validation study using the platform was carried through prospective surgical training with trial randomization. Twenty otolaryngology-head and neck surgery residents, each trainee performing three discrete mock surgical trials (n = 60), performed the initial system validation. Ten of the 20 residents were randomized to perform the surgical trials utilizing the real-time feedback system. The remaining 10 residents were randomized to perform the surgical trials without the feedback system, although the system still could record collision data. Surgical proficiency was measured by Global Evaluative Assessment of Robotic Skills (GEARS) score, time to completion, and tumor resection scores (categorical scale ranging 0-3, describing the adequacy of resection). RESULTS: Major anatomic collisions (greater than 5N of force) negatively affected GEARS robotic skills. A mixed model analysis demonstrated that for every additional occurrence of a major collision, GEARS robotic skills assessment score would decrease by 0.29 points (P = .04). Real-time collision awareness created significantly fewer major (> 5 N) anatomic collisions with the tactile feedback system active (n = 30, mean collisions = 2.9 ± 4.2) as compared with trials without tactile feedback (n = 30, mean collisions = 12.53 ± 23.23) (P < .001). The second assessment measure of time to completion was unaffected by the presence of collisions or by the use of tactile feedback system. The third proficiency assessment was measured with tumor resection grading. Tumor resection scores was significantly (P = .02) improved with collision awareness system activated than trials without collision awareness. CONCLUSION: In order to test our primary hypothesis, a novel TORS training platform was successfully developed that provides collision force measurements including frequency, severity, and duration of anatomic collisions. Additionally, the platform was modulated to provide real-time tactile feedback of the occurrence of out-of-field collisions. Utilizing this custom platform, our hypothesis that anatomic collisions during TORS diminishes surgical performance was supported. Additionally, our secondary hypothesis that subsequent reduction of anatomic collisions improves TORS proficiency was supported by the surgical trial. Dedicated investigation to characterize the effect size and clinical impact is required in order to translate this finding into training curriculums and into clinical utilization. LEVEL OF EVIDENCE: II (Randomized trial) Laryngoscope, 130:S1-S17, 2020.

A Multi-Dimensional Analysis of a Novel Approach for Wireless Stimulation.

The elimination of integrated batteries in biomedical implants holds great promise for improving health outcomes in patients with implantable devices. However, despite extensive research in wireless power transfer, achieving efficient power transfer and effective operational range have remained a hindering challenge within anatomical constraints. OBJECTIVE: We hereby demonstrate an intravascular wireless and batteryless microscale stimulator, designed for (1) low power dissipation via intermittent transmission and (2) reduced fixation mechanical burden via deployment to the anterior cardiac vein (ACV, ∼3.8 mm in diameter). METHODS: We introduced a unique coil design circumferentially confined to a 3 mm diameter hollow-cylinder that was driven by a novel transmitter-based control architecture with improved power efficiency. RESULTS: We examined wireless capacity using heterogenous bovine tissue, demonstrating >5 V stimulation threshold with up to 20 mm transmitter-receiver displacement and 20° of misalignment. Feasibility for human use was validated using Finite Element Method (FEM) simulation of the cardiac cycle, guided by pacer phantom-integrated Magnetic Resonance Images (MRI). CONCLUSION: This system design thus enabled sufficient wireless power transfer in the face of extensive stimulator miniaturization. SIGNIFICANCE: Our successful feasibility studies demonstrated the capacity for minimally invasive deployment and low-risk fixation.

Multi-Modal Haptic Feedback for Grip Force Reduction in Robotic Surgery.

Minimally invasive robotic surgery allows for many advantages over traditional surgical procedures, but the loss of force feedback combined with a potential for strong grasping forces can result in excessive tissue damage. Single modality haptic feedback systems have been designed and tested in an attempt to diminish grasping forces, but the results still fall short of natural performance. A multi-modal pneumatic feedback system was designed to allow for tactile, kinesthetic, and vibrotactile feedback, with the aims of more closely imitating natural touch and further improving the effectiveness of HFS in robotic surgical applications and tasks such as tissue grasping and manipulation. Testing of the multi-modal system yielded very promising results with an average force reduction of nearly 50% between the no feedback and hybrid (tactile and kinesthetic) trials (p < 1.0E-16). The multi-modal system demonstrated an increased reduction over single modality feedback solutions and indicated that the system can help users achieve average grip forces closer to those normally possible with the human hand.

Development of a Transoral Robotic Surgery Training Platform.

Transoral robotic surgery (TORS) presents unique challenges due to difficulty manipulating surgical instruments within the tight confines of the oral cavity. Collisions between the end effectors and anatomical structures can be visualized through the endoscope; however, instrument shaft collisions are outside of the field-of-view. Acquiring the requisite skill set to minimize these collisions is challenging due to the lack of an appropriate training platform. In this paper, we present a TORS training platform with an integrated collision sensing system and real-time haptic feedback. Preliminary testing involved the recruitment of 10 Otolaryngology residents assigned to `feedback' (N=5) and `no feedback' (N=5) groups. Each trainee performed three mock surgical procedures involving the resection of a tumor from the base of the tongue. Superior surgical performance was observed in the feedback group suggesting that haptic feedback will enhance the acquisition of surgical skills.

Characterization of perfused and sectioned liver tissue in a full indentation cycle using a visco-hyperelastic model.

Realistic modeling of biologic material is required for optimizing fidelity in computer-aided surgical training and assistance systems. The modeling of liver tissue has remained challenging due to its nonlinear viscoelastic properties and high hysteresis of the stress-strain relation. While prior studies have described the behavior of liver tissue during the loading status (in elongation, compression, or indentation tests) or unloading status (in stress relaxation or creep tests), a hysteresis curve with both loading and unloading processes was incompletely defined. We seek to use a single material model to characterize the mechanical properties of liver tissue in a full indentation cycle ex vivo perfused and then sectioned. Based on measurements taken from ex-vivo perfused porcine livers, we converted force-displacement curves to stress-strain curves and developed a visco-hyperelastic constitutive model to characterize the liver's mechanical behavior at different locations under various rates of indentation (1, 2, 5, 10, and 20 mm/s). The proposed model is a mixed visco-hyperelastic model with up to 6 coefficients. The normalized root mean square standard deviations of fitted curves are less than 5% and 10% in low (<0.05) and high strain (>0.3) conditions respectively.

Suture Breakage Warning System for Robotic Surgery.

As robotic surgery has increased in popularity, the lack of haptic feedback has become a growing issue due to the application of excessive forces that may lead to clinical problems such as intraoperative and postoperative suture breakage. Previous suture breakage warning systems have largely depended on visual and/or auditory feedback modalities, which have been shown to increase cognitive load and reduce operator performance. This work catalogues a new sensing technology and haptic feedback system (HFS) that can reduce instances of suture failure without negatively impacting performance outcomes including knot quality. Suture breakage is common in knot-tying as the pulling motion introduces prominent shear forces. A shear sensor mountable on the da Vinci robotic surgical system's Cadiere grasper detects forces that correlate to the suture's internal tension. HFS then provides vibration feedback to the operator as forces near a particular material's failure load. To validate the system, subjects tightened a total of four knots, two with the Haptic Feedback System (HFS) and two without feedback. The number of suture breakages were recorded and knot fidelity was evaluated by measuring knot slippage. Results showed that instances of suture failure were significantly reduced when HFS was enabled (p = 0.0078). Notably, knots tied with HFS also showed improved quality compared to those tied without feedback (p = 0.010). The results highlight the value of HFS in improving robotic procedure outcomes by reducing instances of suture failures, producing better knots, and reducing the need for corrective measures.

Artificial palpation in robotic surgery using haptic feedback.

BACKGROUND: The loss of tactile feedback in minimally invasive robotic surgery remains a major challenge to the expanding field. With visual cue compensation alone, tissue characterization via palpation proves to be immensely difficult. This work evaluates a bimodal vibrotactile system as a means of conveying applied forces to simulate haptic feedback in two sets of studies simulating an artificial palpation task using the da Vinci surgical robot. METHODS: Subjects in the first study were tasked with localizing an embedded vessel in a soft tissue phantom using a single-sensor unit. In the second study, subjects localized tumor-like structures using a three-sensor array. In both sets of studies, subjects completed the task under three trial conditions: no feedback, normal force tactile feedback, and hybrid vibrotactile feedback. Recordings of correct localization, incorrect localization, and time-to-completion were used to evaluate performance outcomes. RESULTS: With the addition of vibrotactile and pneumatic feedback, significant improvements in the percentage of correct localization attempts were detected (p = 0.0001 and p = 0.0459, respectively) during the first experiment with phantom vessels. Similarly, significant improvements in correct localization were found with the addition of vibrotactile (p = 2.57E-5) and pneumatic significance (p = 8.54E-5) were observed in the second experiment involving tumor phantoms. CONCLUSIONS: This work demonstrates not only the superior benefits of a multi-modal feedback over traditional single-modality feedback, but also the effectiveness of vibration in providing haptic feedback to artificial palpation systems.

Diffusion of robotic-assisted laparoscopic technology across specialties: a national study from 2008 to 2013.

INTRODUCTION: Robotic-assisted procedures were frequently found to have similar outcomes and indications to their laparoscopic counterparts, yet significant variation existed in the acceptance of robotic-assisted technology between surgical specialties and procedures. We performed a retrospective cohort study investigating factors associated with the adoption of robotic assistance across the United States from 2008 to 2013. METHODS: Using the Nationwide Inpatient Sample database, patient- and hospital-level variables were examined for differential distribution between robotic-assisted and conventional laparoscopic procedures. Multilevel logistic regression models were constructed to identify independent factors associated with robotic adoption. Furthermore, cases were stratified by procedure and specialty before being ranked according to proportion of robotic-assistance adoption. Correlation was examined between robotic-assistance adoption and relative outcome in comparison with conventional laparoscopic procedures. RESULTS: The national robotic case volume doubled over the five-year period while a gradual decline in laparoscopic case volume was observed, resulting in an increase in the proportion of procedures performed with robotic assistance from 6.8 to 17%. Patients receiving robotic procedures were more likely to be younger, males, white, privately insured, more affluent, and with less comorbidities. These differences have been decreasing over the study period. The three specialties with the highest proportion of robotic-assisted laparoscopic procedures were urology (34.1%), gynecology (11.0%), and endocrine surgery (9.4%). However, no significant association existed between the frequency of robotic-assistance usage and relative outcome statistics such as mortality, charge, or length of stay. CONCLUSION: The variation in robotic-assistance adoption between specialties and procedures could not be attributable to clinical outcomes alone. Cultural readiness toward adopting new technology within specialty and target anatomic areas appear to be major determining factors influencing its adoption.

Grasper integrated tri-axial force sensor system for robotic minimally invasive surgery.

This paper describes the design, microfabrication, and characterization of a miniature force sensor for providing tactile feedback in robotic surgical systems. We demonstrate for the first time a microfabricated sensor that can provide triaxial sensing (normal, x-shear, y-shear) in a single sensor element that can be integrated with commercial robotic surgical graspers. Features of this capacitive force sensor include differential sensing in the shear directions as well as a design where all electrical connections are on one side, leaving the backside pristine as the sensing face. The sensor readout is performed by a custom-designed printed circuit board with 24-bit resolution. Experimental results of sensor performance show normal force resolution of 0.055 N, x-shear resolution of 0.25 N, and y-shear resolution of 1.45 N, all of which fall in a range of clinically relevant forces.

Inductively powered wireless pacing via a miniature pacemaker and remote stimulation control system.

Pacemakers have existed for decades as a means to restore cardiac electrical rhythms. However, lead-related complications have remained a clinical challenge. While market-released leadless devices have addressed some of the issues, their pacer-integrated batteries cause new health risks and functional limitations. Inductive power transfer enables wireless powering of bioelectronic devices; however, Specific Absorption Rate and size limitations reduce power efficiency for biomedical applications. We designed a remote-controlled system in which power requirements were significantly reduced via intermittent power transfer to control stimulation intervals. In parallel, the cardiac component was miniaturized to facilitate intravascular deployment into the anterior cardiac vein. Given size constraints, efficiency was optimal via a circular receiver coil wrapped into a half-cylinder with a meandering tail. The pacemaker was epicardially tested in a euthanized pig at 60 beats per minute, 2 V amplitude, and 1 ms pulse width, restoring mean arterial pressure from 0 to 37 mmHg. Power consumption was 1 mW at a range of > 3 cm with no misalignment and at 2 cm with 45° displacement misalignment, 45° x-axis angular misalignment, or 45° y-axis angular misalignment. Thus, we demonstrated a remote-controlled miniaturized pacing system with low power consumption, thereby providing a basis for the next generation of wireless implantable devices.

Visual-perceptual mismatch in robotic surgery.

BACKGROUND: The principal objective of the experiment was to analyze the effects of the clutch operation of robotic surgical systems on the performance of the operator. The relative coordinate system introduced by the clutch operation can introduce a visual-perceptual mismatch which can potentially have negative impact on a surgeon's performance. We also assess the impact of the introduction of additional tactile sensory information on reducing the impact of visual-perceptual mismatch on the performance of the operator. METHODS: We asked 45 novice subjects to complete peg transfers using the da Vinci IS 1200 system with grasper-mounted, normal force sensors. The task involves picking up a peg with one of the robotic arms, passing it to the other arm, and then placing it on the opposite side of the view. Subjects were divided into three groups: aligned group (no mismatch), the misaligned group (10 cm z axis mismatch), and the haptics-misaligned group (haptic feedback and z axis mismatch). Each subject performed the task five times, during which the grip force, time of completion, and number of faults were recorded. RESULTS: Compared to the subjects that performed the tasks using a properly aligned controller/arm configuration, subjects with a single-axis misalignment showed significantly more peg drops (p = 0.011) and longer time to completion (p < 0.001). Additionally, it was observed that addition of tactile feedback helps reduce the negative effects of visual-perceptual mismatch in some cases. Grip force data recorded from grasper-mounted sensors showed no difference between the different groups. CONCLUSIONS: The visual-perceptual mismatch created by the misalignment of the robotic controls relative to the robotic arms has a negative impact on the operator of a robotic surgical system. Introduction of other sensory information and haptic feedback systems can help in potentially reducing this effect.

Tensile strength and failure load of sutures for robotic surgery.

BACKGROUND: Robotic surgical platforms have seen increased use among minimally invasive gastrointestinal surgeons (von Fraunhofer et al. in J Biomed Mater Res 19(5):595-600, 1985. doi: 10.1002/jbm.820190511 ). However, these systems still suffer from lack of haptic feedback, which results in exertion of excessive force, often leading to suture failures (Barbash et al. in Ann Surg 259(1):1-6, 2014. doi: 10.1097/SLA.0b013e3182a5c8b8 ). This work catalogs tensile strength and failure load among commonly used sutures in an effort to prevent robotic surgical consoles from exceeding identified thresholds. Trials were thus conducted on common sutures varying in material type, gauge size, rate of pulling force, and method of applied force. METHODS: Polydioxanone, Silk, Vicryl, and Prolene, gauges 5-0 to 1-0, were pulled till failure using a commercial mechanical testing system. 2-0 and 3-0 sutures were further tested for the effect of pull rate on failure load at rates of 50, 200, and 400 mm/min. 3-0 sutures were also pulled till failure using a da Vinci robotic surgical system in unlooped, looped, and at the needle body arrangements. RESULTS: Generally, Vicryl and PDS sutures had the highest mechanical strength (47-179 kN/cm2), while Silk had the lowest (40-106 kN/cm2). Larger diameter sutures withstand higher total force, but finer gauges consistently show higher force per unit area. The difference between material types becomes increasingly significant as the diameters decrease. Comparisons of identical suture materials and gauges show 27-50% improvement in the tensile strength over data obtained in 1985 (Ballantyne in Surg Endosc Other Interv Tech 16(10):1389-1402, 2002. doi: 10.1007/s00464-001-8283-7 ). No significant differences were observed when sutures were pulled at different rates. Reduction in suture strength appeared to be strongly affected by the technique used to manipulate the suture. CONCLUSIONS: Availability of suture tensile strength and failure load data will help define software safety protocols for alerting a surgeon prior to suture failure during robotic surgery. Awareness of suture strength weakening with direct instrument manipulation may lead to the development of better techniques to further reduce intraoperative suture breakage.

Brain-computer interface controlled functional electrical stimulation system for ankle movement.

BACKGROUND: Many neurological conditions, such as stroke, spinal cord injury, and traumatic brain injury, can cause chronic gait function impairment due to foot-drop. Current physiotherapy techniques provide only a limited degree of motor function recovery in these individuals, and therefore novel therapies are needed. Brain-computer interface (BCI) is a relatively novel technology with a potential to restore, substitute, or augment lost motor behaviors in patients with neurological injuries. Here, we describe the first successful integration of a noninvasive electroencephalogram (EEG)-based BCI with a noninvasive functional electrical stimulation (FES) system that enables the direct brain control of foot dorsiflexion in able-bodied individuals. METHODS: A noninvasive EEG-based BCI system was integrated with a noninvasive FES system for foot dorsiflexion. Subjects underwent computer-cued epochs of repetitive foot dorsiflexion and idling while their EEG signals were recorded and stored for offline analysis. The analysis generated a prediction model that allowed EEG data to be analyzed and classified in real time during online BCI operation. The real-time online performance of the integrated BCI-FES system was tested in a group of five able-bodied subjects who used repetitive foot dorsiflexion to elicit BCI-FES mediated dorsiflexion of the contralateral foot. RESULTS: Five able-bodied subjects performed 10 alternations of idling and repetitive foot dorsifiexion to trigger BCI-FES mediated dorsifiexion of the contralateral foot. The epochs of BCI-FES mediated foot dorsifiexion were highly correlated with the epochs of voluntary foot dorsifiexion (correlation coefficient ranged between 0.59 and 0.77) with latencies ranging from 1.4 sec to 3.1 sec. In addition, all subjects achieved a 100% BCI-FES response (no omissions), and one subject had a single false alarm. CONCLUSIONS: This study suggests that the integration of a noninvasive BCI with a lower-extremity FES system is feasible. With additional modifications, the proposed BCI-FES system may offer a novel and effective therapy in the neuro-rehabilitation of individuals with lower extremity paralysis due to neurological injuries.