In Vivo Layer-Specific Mechanical Characterization of Porcine Stomach Tissue Using a Customized Ultrasound Elastography System.

This paper presents in vivo mechanical characterization of the muscularis, submucosa, and mucosa of the porcine stomach wall under large deformation loading. This is particularly important for the development of gastrointestinal pathology-specific surgical intervention techniques. The study is based on testing the cardiac and fundic glandular stomach regions using a custom-developed compression ultrasound elastography system. Particular attention has been paid to elucidate the heterogeneity and anisotropy of tissue response. A Fung hyperelastic material model has been used to model the mechanical response of each tissue layer. A univariate analysis comparing the initial shear moduli of the three layers indicates that the muscularis (5.69 ± 4.06 kPa) is the stiffest followed by the submucosa (3.04 ± 3.32 kPa) and the mucosa (0.56 ± 0.28 kPa). The muscularis is found to be strongly distinguishable from the mucosa tissue in the cardiac and fundic regions based on a multivariate discriminant analysis. The cardiac muscularis is observed to be stiffer than the fundic muscularis tissue (shear moduli of 7.96 ± 3.82 kPa versus 3.42 ± 2.96 kPa), more anisotropic (anisotropic parameter of 2.21 ± 0.77 versus 1.41 ± 0.38), and strongly distinguishable from its fundic counterpart. The results are consistent with the tissue morphology and are in accordance with our previous ex vivo tissue study. Finally, a univariate comparison of the in vivo and ex vivo initial shear moduli for each layer shows that the muscularis and submucosa tissues are softer while in vivo, but the mucosa tissue is stiffer while in vivo. The results concerning the mechanical properties highlight the inhomogeneity and anisotropy of multilayer stomach tissue.

Ultrasound elastography reliably identifies altered mechanical properties of burned soft tissues.

Although burn injury to the skin and subcutaneous tissues is common in both civilian and military scenarios, a significant knowledge gap exists in quantifying changes in tissue properties as a result of burns. In this study, we present a noninvasive technique based on ultrasound elastography which can reliably assess altered nonlinear mechanical properties of a burned tissue. In particular, ex vivo porcine skin tissues have been exposed to four different burn conditions: (i) 200°F for 10s, (ii) 200°F for 30s, (iii) 450°F for 10s, and (iv) 450°F for 30s. A custom-developed instrument including a robotically controlled ultrasound probe and force sensors has been used to compress the tissue samples to compute two parameters (C10 and C20) of a reduced second-order polynomial hyperelastic material model. The results indicate that while the linear model parameter (C10) does not show a statistically significant difference between the test conditions, the nonlinear model parameter (C20) reliably identifies three (ii-iv) of the four cases (p<0.05) when comparing burned with unburned tissues with a classification accuracy of 60-87%. Additionally, softening of the tissue is observed because of the change in structure of the collagen fibers. The ultrasound elastography-based technique has potential for application under in vivo conditions, which is left for future work.

In Situ Mechanical Characterization of Multilayer Soft Tissue Using Ultrasound Imaging.

In this paper, we report the development of a technique to characterize layer-specific nonlinear material properties of soft tissue in situ with the potential for in vivo testing. A soft tissue elastography robotic arm system comprising of a robotically manipulated 30 MHz high-resolution ultrasound probe, a custom designed compression head, and load cells has been developed to perform compression ultrasound imaging on the target tissue and measure reaction forces. A multilayer finite element model is iteratively optimized to identify the material coefficients of each layer. Validation has been performed using tissue mimicking agar-based phantoms with a low relative error of ∼7% for two-layer phantoms and ∼10% error for three layer phantoms when compared to known ground-truth values obtained using a commercial material testing system. The technique has then been used to successfully determine the in situ layer-specific mechanical properties of intact porcine stomach. The mean C10 and C20 for a second-order reduced polynomial material model were determined for the muscularis (6.41 ± 0.60, 4.29 ± 1.87 kPa), submucosal (5.21 ± 0.57, 3.68 ± 3.01 kPa), and mucosal layers (0.06 ± 0.02, 0.09 ± 0.24 kPa). Such a system can be utilized to perform in vivo mechanical characterization, which is left as future work.

Face and content validation of a Virtual Translumenal Endoscopic Surgery Trainer (VTEST™).

BACKGROUND: Natural orifice translumenal endoscopic surgery (NOTES) is an emerging surgical paradigm, where peritoneal access is achieved through one of the natural orifices of the body. It is being reported as a safe and feasible surgical technique with significantly reduced external scarring. Virtual Translumenal Endoscopic Surgical Trainer (VTEST™) is the first virtual reality simulator for the NOTES. The VTEST™ simulator was developed to train surgeons in the hybrid transvaginal NOTES cholecystectomy procedure. The initial version of the VTEST™ simulator underwent face validation at the 2013 Natural Orifice Surgery Consortium for Assessment and Research (NOSCAR) summit. Several areas of improvement were identified as a result, and the corresponding modifications were implemented in the simulator. This manuscript outlines the results of the subsequent evaluation study, performed in order to assess the face and content validity of the latest VTEST™ simulator. METHODS: Twelve subjects participated in an institutional review board-approved study that took place at the 2014 NOSCAR summit. Six of the 12 subjects, who are experts with NOTES experience, were used for face and content validation. The subjects performed the hybrid transvaginal NOTES cholecystectomy procedure on VTEST™ that included identifying the Calot's triangle, clipping and cutting the cystic duct/artery, and detaching the gallbladder. The subjects then answered five-point Likert scale feedback questionnaires for face and content validity. RESULTS: Overall, subjects rated 12/15 questions as 3.0 or greater (60 %), for face validity questions regarding the realism of the anatomical features, interface, and the tasks. Subjects also highly rated the usefulness of the simulator in learning the fundamental NOTES technical skills (3.50 ± 0.84). Content validity results indicate a high level of usefulness of the VTEST™ for training prior to operating room experience (4.17 ± 0.75).

Development of a Soft Tissue Elastography Robotic Arm (STiERA).

High fidelity surgical simulations must rely upon accurate soft tissue models to ensure realism of the simulations. Simulating multi-layer tissue becomes increasingly complex due to the specific mechanical properties of each individual layer. We have developed a Soft Tissue Elastography Robotic Arm (STiERA) system capable of identifying layer specific properties of multi-layer constructs while maintaining the integrity of each layer. The system was validated using tissue mimicking agar gel phantoms and showed great promise by identifying the layer specific properties with accuracy of greater than 80% when compared to known ground truth values from a commercial material testing system.

Development of a Haptic Interface for Natural Orifice Translumenal Endoscopic Surgery Simulation.

Natural orifice translumenal endoscopic surgery (NOTES) is a minimally invasive procedure, which utilizes the body's natural orifices to gain access to the peritoneal cavity. The NOTES procedure is designed to minimize external scarring and patient trauma, however flexible endoscopy based pure NOTES procedures require critical scope handling skills. The delicate nature of the NOTES procedure requires extensive training. Thus, to improve access to training while reducing risk to patients, we have designed and developed the VTEST, a virtual reality NOTES simulator. As part of the simulator, a novel decoupled 2-DOF haptic device was developed to provide realistic force feedback to the user in training. A series of experiments were performed to determine the behavioral characteristics of the device. The device was found capable of rendering up to 5.62N and 0.190 Nm of continuous force and torque in the translational and rotational DOF, respectively. The device possesses 18.1 and 5.7 Hz of force bandwidth in the translational and rotational DOF, respectively. A feedforward friction compensator was also successfully implemented to minimize the negative impact of friction during the interaction with the device. In this work, we have presented the detailed development and evaluation of the haptic device for the VTEST.

Graphic and haptic simulation for transvaginal cholecystectomy training in NOTES.

BACKGROUND: Natural Orifice Transluminal Endoscopic Surgery (NOTES) provides an emerging surgical technique which usually needs a long learning curve for surgeons. Virtual reality (VR) medical simulators with vision and haptic feedback can usually offer an efficient and cost-effective alternative without risk to the traditional training approaches. Under this motivation, we developed the first virtual reality simulator for transvaginal cholecystectomy in NOTES (VTEST™). METHODS: This VR-based surgical simulator aims to simulate the hybrid NOTES of cholecystectomy. We use a 6DOF haptic device and a tracking sensor to construct the core hardware component of simulator. For software, an innovative approach based on the inner-spheres is presented to deform the organs in real time. To handle the frequent collision between soft tissue and surgical instruments, an adaptive collision detection method based on GPU is designed and implemented. To give a realistic visual performance of gallbladder fat tissue removal by cautery hook, a multi-layer hexahedral model is presented to simulate the electric dissection of fat tissue. RESULTS: From the experimental results, trainees can operate in real time with high degree of stability and fidelity. A preliminary study was also performed to evaluate the realism and the usefulness of this hybrid NOTES simulator. CONCLUSIONS: This prototyped simulation system has been verified by surgeons through a pilot study. Some items of its visual performance and the utility were rated fairly high by the participants during testing. It exhibits the potential to improve the surgical skills of trainee and effectively shorten their learning curve.

Towards immersive virtual reality (iVR): a route to surgical expertise.

Surgery is characterized by complex tasks performed in stressful environments. To enhance patient safety and reduce errors, surgeons must be trained in environments that mimic the actual clinical setting. Rasmussen's model of human behavior indicates that errors in surgical procedures may be skill-, rule-, or knowledge-based. While skill-based behavior and some rule-based behavior may be taught using box trainers and ex vivo or in vivo animal models, we posit that multimodal immersive virtual reality (iVR) that includes high-fidelity visual as well as other sensory feedback in a seamless fashion provides the only means of achieving true surgical expertise by addressing all three levels of human behavior. While the field of virtual reality is not new, realization of the goals of complete immersion is challenging and has been recognized as a Grand Challenge by the National Academy of Engineering. Recent technological advances in both interface and computational hardware have generated significant enthusiasm in this field. In this paper, we discuss convergence of some of these technologies and possible evolution of the field in the near term.

Characterization of force and torque interactions during a simulated transgastric appendectomy procedure.

We have developed an instrumented endoscope grip handle equipped with a six-axis load cell and measured forces and torques during a simulated transgastric natural orifice translumenal endoscopic surgery appendectomy procedure performed in an EASIE-R ex vivo simulator. The data were collected from ten participating surgeons of varying degrees of expertise which was analyzed to compute a set of six force and torque parameters for each coordinate axis for each of the nine tasks of the appendectomy procedure. The mean push/pull force was found to be 3.64 N (σ = 3.54 N) in the push direction and the mean torque was 3.3 N · mm (σ = 38.6 N · mm) in the counterclockwise direction about the push/pull axis. Most interestingly, the force and torque data about the nondominant x and z axes showed a statistically significant difference (p < 0.05) between the expert and novice groups for five of the nine tasks. These data may be useful in developing surgical platforms especially new haptic devices and simulation systems for emerging natural orifice procedures.

Development of a Virtual Reality Simulator for Natural Orifice Translumenal Endoscopic Surgery (NOTES) Cholecystectomy Procedure.

The first virtual-reality-based simulator for Natural Orifice Translumenal Endoscopic Surgery (NOTES) is developed called the Virtual Translumenal Endoscopic Surgery Trainer (VTESTTM). VTESTTM aims to simulate hybrid NOTES cholecystectomy procedure using a rigid scope inserted through the vaginal port. The hardware interface is designed for accurate motion tracking of the scope and laparoscopic instruments to reproduce the unique hand-eye coordination. The haptic-enabled multimodal interactive simulation includes exposing the Calot's triangle and detaching the gall bladder while performing electrosurgery. The developed VTESTTM was demonstrated and validated at NOSCAR 2013.

A Decoupled 2 DOF Force Feedback Mechanism for the Virtual Translumenal Endoscopic Surgical Trainer (VTEST.

Natural orifice translumenal endoscopic surgery (NOTES) is a minimally invasive procedure which utilizes the body's natural orifices to gain access to the peritoneal cavity. The VTEST is a virtual reality NOTES cholecystectomy simulator being built at the CeMSIM at RPI. We have developed a 2 DOF decoupled haptic device, which can provide translational and rotational haptic feedback to the user handling the flexible endoscope. Preliminary results indicate the device is capable of providing realistic feedback to the user while operating the device.

Kinematic Measures for Evaluating Surgical Skills in Natural Orifice Translumenal Endoscopic Surgery (NOTES).

Natural Orifice Translumenal Endoscopic Surgery is an emerging procedure that requires training and adoption to be successful. Currently no objective performance metrics exist for evaluating skills for NOTES. In this work, we have improved upon our previous study on objective performance metrics using kinematic measures by introducing two new measures, the flex and the roll and recruiting more subjects to increase the statistical power. The measures were evaluated in a transgastric NOTES appendectomy procedure performed with ex-vivo organs using the EASIE-RTM trainer box. Four motion tracking sensors attached to an endoscope were used to measure the scope position and orientation to compute the kinematic measures. Results from our study showed that completion time, economy of motion, jerk and roll of the scope are valid kinematic measures to differentiate between expert and novice NOTES surgeons.

System characterization of a novel haptic interface for natural orifice translumenal endoscopic surgery simulation.

Natural orifice translumenal endoscopic surgery (NOTES) is a minimally invasive procedure, which utilizes the body's natural orifices to gain access to the peritoneal cavity. The VTEST(©) is a virtual reality NOTES simulator developed at the CeMSIM at RPI to train surgeons in NOTES. A novel 2 DOF decoupled haptic device was designed and built for this simulator. The haptic device can render 5.62 N and 190.05 N-mm of continuous force and torque respectively. In this work we have evaluated the haptic interface and developed a model to accurately describe the system behavior, to further incorporate into an impedance type controller for realistic haptic rendering in the VTEST(©).

Objective performance measures using motion sensors on an endoscopic tool for evaluating skills in natural orifice translumenal endoscopic surgery (NOTES).

Natural orifice translumenal endoscopic surgery is an emerging procedure. High fidelity virtual reality-based simulators allow development of new surgical procedures and tools and train medical personnel without risk to human patients. As part of a project funded by the National Institutes of Health, we are developing a Virtual Transluminal Endoscopic Surgery Trainer (VTEST TM) for this purpose. In this work, objective performance measures derived from motion tracking sensors attached to an endoscope was tested for the transgastric NOTES appendectomy procedure performed with ex-vivo pig organs using the EASIE-R(TM) trainer box. Results from our study shows that both completion time and economy of motion parameters were able to differentiate between expert and novice NOTES surgeons with p value of 0.039 and 0.02 respectively. Jerk computed on sensor 2 data also showed significant results (p = 0.02). We plan to incorporate these objective performance measures in VTEST(TM).

The development of a haptic interface for the Virtual Translumenal Endoscopic Surgical Trainer (VTEST.

Natural orifice translumenal endoscopic surgery (NOTES) is an experimental surgical technique with benefits including reduced pain, post operative recovery period and better cosmesis compared to traditional laparoscopic procedures. In a pure NOTES procedure, a flexible endoscope is used for performing the surgery and visualization. The Virtual Translumenal Endoscopic Surgical Trainer (VTEST(TM)) is being developed as a platform to train for NOTES procedures and innovate NOTES tools and techniques. In this work we report the design specification for the hardware interface to be used for VTEST(TM).

The use of rotational optical encoders for dial sensing in the Virtual translumenal Endoscopic Surgical Trainer (VTEST.

Natural orifice translumenal endoscopic surgery (NOTES) is a minimally invasive procedure, known for its scar-less nature and short post operative recovery periods. A critical skill necessary for a NOTES procedure is the surgeon's ability to navigate and gain visualization of the target organ, which is done by moving the endoscope tip using the dials on the handle. We have developed an accurate and high resolution optical encoder based system to measure that dial manipulations, as part of a larger project to develop a VR-NOTES surgical simulator.

Microsoft Kinect based head tracking for Life Size Collaborative Surgical Simulation Environments (LS-CollaSSLE).

Virtual surgical skills trainers are proving to be very useful for the medical training community. With efforts to increase patient safety and surgeon expertise, the need for surgical skills trainers that provide training in an operating room (OR) like condition is now more pressing. To allow for virtual surgery simulators to be instructed in an OR-like setting we have created a large display based immersive surgical simulation environment. Using the Microsoft Kinect we have created a real-time simulation environment that tracks the test user and appropriately adjust the perspective of the virtual OR for an immersive virtual experience.

Use of a linear motion stroke potentiometer as a high precision sensor for linear translation in a laparoscopic ligating loop simulation.

Virtual Basic Laparoscopic Skills Trainer (VBLaST) is a virtual reality trainer that replicates the Fundamentals of Laparoscopic Surgery (FLS) tasks for training in minimally invasive surgery. For the ligation loop task, we have developed a novel hardware interface using a linear motion stroke potentiometer to accurately sense the linear translation of the ligation loop and a mechanism to attach the tool interface to a PHANToM Omni for force feedback. Testing shows that the interface provided a realistic feel and control of the loop similar to the endoloop device used in FLS ligation loop task.

ToolTrack™: a compact, low-cost system for measuring surgical tool motion.

Accurate measurement of tool motion in minimally invasive procedures is an essential component of proficiency assessment. This is particularly important to automate the scoring procedures in, e.g., the Fundamentals of Laparoscopic Surgery (FLS) trainer box. Existing techniques are bulky, require extensive modifications to the surgical tool or trocar mechanism and are expensive. In this work, we propose a new system - the ToolTrack™ consisting of an optical mouse sensor and a MEMS inertial unit that can be easily integrated with any laparoscopic tool, provide accurate and reliable sensing, is light weight and low cost.