Cost-effectiveness of decellularised bone allograft compared with fresh-frozen bone allograft for acetabular impaction bone grafting during a revision hip arthroplasty in the UK.

OBJECTIVES: Fresh-frozen allograft is the gold-standard bone graft material used during revision hip arthroplasty. However, new technology has been developed to manufacture decellularised bone with potentially better graft incorporation. As these grafts cost more to manufacture, the aim of this cost-effectiveness study was to estimate whether the potential health benefit of decellularised bone allograft outweighs their increased cost. STUDY DESIGN: A Markov model was constructed to estimate the costs and the quality-adjusted life years of impaction bone grafting during a revision hip arthroplasty. SETTING: This study took the perspective of the National Health Service in the UK. PARTICIPANTS: The Markov model includes patients undergoing a revision hip arthroplasty in the UK. INTERVENTION: Impaction bone grafting during a revision hip arthroplasty using either decellularised bone allograft or fresh-frozen allograft. MEASURES: Outcome measures included: total costs and quality-adjusted life years of both interventions over the lifetime of the model; and incremental cost-effectiveness ratios for both graft types, using base case parameters, univariate sensitivity analysis and probabilistic analysis. RESULTS: The incremental cost-effectiveness ratio for the base case model was found to be £270 059 per quality-adjusted life year. Univariate sensitivity analysis found that changing the discount rate, the decellularised bone graft cost, age of the patient cohort and the revision rate all had a significant effect on the incremental cost-effectiveness ratio. CONCLUSIONS: As there are no clinical studies of impaction bone grafting using a decellularised bone allograft, there is a high level of uncertainty around the costs of producing a decellularised bone allograft and the potential health benefits. However, if a decellularised bone graft was manufactured for £2887 and lowered the re-revision rate to less than 64 cases per year per 10 000 revision patients, then it would most likely be cost-effective compared with fresh-frozen allograft.

Robust endoscopic image mosaicking via fusion of multimodal estimation.

We propose an endoscopic image mosaicking algorithm that is robust to light conditioning changes, specular reflections, and feature-less scenes. These conditions are especially common in minimally invasive surgery where the light source moves with the camera to dynamically illuminate close range scenes. This makes it difficult for a single image registration method to robustly track camera motion and then generate consistent mosaics of the expanded surgical scene across different and heterogeneous environments. Instead of relying on one specialised feature extractor or image registration method, we propose to fuse different image registration algorithms according to their uncertainties, formulating the problem as affine pose graph optimisation. This allows to combine landmarks, dense intensity registration, and learning-based approaches in a single framework. To demonstrate our application we consider deep learning-based optical flow, hand-crafted features, and intensity-based registration, however, the framework is general and could take as input other sources of motion estimation, including other sensor modalities. We validate the performance of our approach on three datasets with very different characteristics to highlighting its generalisability, demonstrating the advantages of our proposed fusion framework. While each individual registration algorithm eventually fails drastically on certain surgical scenes, the fusion approach flexibly determines which algorithms to use and in which proportion to more robustly obtain consistent mosaics.

Optimization and fabrication of programmable domains for soft magnetic robots: A review.

Driven by the aim of realizing functional robotic systems at the milli- and submillimetre scale for biomedical applications, the area of magnetically driven soft devices has received significant recent attention. This has resulted in a new generation of magnetically controlled soft robots with patterns of embedded, programmable domains throughout their structures. This type of programmable magnetic profiling equips magnetic soft robots with shape programmable memory and can be achieved through the distribution of discrete domains (voxels) with variable magnetic densities and magnetization directions. This approach has produced highly compliant, and often bio-inspired structures that are well suited to biomedical applications at small scales, including microfluidic transport and shape-forming surgical catheters. However, to unlock the full potential of magnetic soft robots with improved designs and control, significant challenges remain in their compositional optimization and fabrication. This review considers recent advances and challenges in the interlinked optimization and fabrication aspects of programmable domains within magnetic soft robots. Through a combination of improvements in the computational capacity of novel optimization methods with advances in the resolution, material selection and automation of existing and novel fabrication methods, significant further developments in programmable magnetic soft robots may be realized.

Micro-scale aerosol jet printing of superparamagnetic Fe3O4 nanoparticle patterns.

The opportunity to create different patterns of magnetic nanoparticles on surfaces is highly desirable across many technological and biomedical applications. In this paper, this ability is demonstrated for the first time using a computer-controlled aerosol jet printing (AJP) technology. AJP is an emerging digitally driven, non-contact and mask-less printing process which has distinguishing advantages over other patterning technologies as it offers high-resolution and versatile direct-write deposition of a wide range of materials onto a variety of substrates. This research demonstrates the ability of AJP to reliably print large-area, fine-feature patterns of superparamagnetic iron oxide nanoparticles (SPIONs) onto both rigid material (glass) and soft and flexible materials (polydimethylsiloxane (PDMS) films and poly-L-lactic acid (PLLA) nanofilms). Investigation identified and controlled influential process variables which permitted feature sizes in the region of 20 µm to be realised. This method could be employed for a wide range of applications that require a flexible and responsive process that permits high yield and rapid patterning of magnetic material over large areas. As a first proof of concept, we present patterned magnetic nanofilms with enhanced manipulability under external magnetic field gradient control and which are capable of performing complex movements such as rotation and bending, with applicability to soft robotics and biomedical engineering applications.

Traditional Multiwell Plates and Petri Dishes Limit the Evaluation of the Effects of Ultrasound on Cells In Vitro.

Ultrasound accelerates healing in fractured bone; however, the mechanisms responsible are poorly understood. Experimental setups and ultrasound exposures vary or are not adequately characterized across studies, resulting in inter-study variation and difficulty in concluding biological effects. This study investigated experimental variability introduced through the cell culture platform used. Continuous wave ultrasound (45 kHz; 10, 25 or 75 mW/cm2, 5 min/d) was applied, using a Duoson device, to Saos-2 cells seeded in multiwell plates or Petri dishes. Pressure field and vibration quantification and finite-element modelling suggested formation of complex interference patterns, resulting in localized displacement and velocity gradients, more pronounced in multiwell plates. Cell experiments revealed lower metabolic activities in both culture platforms at higher ultrasound intensities and absence of mineralization in certain regions of multiwell plates but not in Petri dishes. Thus, the same transducer produced variable results in different cell culture platforms. Analysis on Petri dishes further revealed that higher intensities reduced vinculin expression and distorted cell morphology, while causing mitochondrial and endoplasmic reticulum damage and accumulation of cells in sub-G1 phase, leading to cell death. More defined experimental setups and reproducible ultrasound exposure systems are required to study the real effect of ultrasound on cells for development of effective ultrasound-based therapies not just limited to bone repair and regeneration.

Patient-Specific Magnetic Catheters for Atraumatic Autonomous Endoscopy.

Despite increasing interest in minimally invasive surgical techniques and related developments in flexible endoscopes and catheters, follow-the-leader motion remains elusive. Following the path of least resistance through a tortuous and potentially delicate environment without relying on interaction with the surrounding anatomy requires the control of many degrees of freedom. This typically results in large-diameter instruments. One viable solution to obtain dexterity without increasing size is via multiple-point magnetic actuation over the length of the catheter. The main challenge of this approach is planning magnetic interaction to allow the catheter to adapt to the surrounding anatomy during navigation. We design and manufacture a fully shape-forming, soft magnetic catheter of 80 mm length and 2 mm diameter, capable of navigating a human anatomy in a follow-the-leader fashion. Although this system could be exploited for a range of endoscopic or intravascular applications, here we demonstrate its efficacy for navigational bronchoscopy. From a patient-specific preoperative scan, we optimize the catheters' magnetization profiles and the shape-forming actuating field. To generate the required transient magnetic fields, a dual-robot arm system is employed. We fabricate three separate prototypes to demonstrate minimal contact navigation through a three-dimensional bronchial tree phantom under precomputed robotic control. We also compare a further four separate optimally designed catheters against mechanically equivalent designs with axial magnetization profiles along their length and only at the tip. Using our follow-the-leader approach, we demonstrate up to 50% more accurate tracking, 50% reduction in obstacle contact time during navigation over the state of the art, and an improvement in targeting error of 90%.

Closed-loop control of soft continuum manipulators under tip follower actuation.

Continuum manipulators, inspired by nature, have drawn significant interest within the robotics community. They can facilitate motion within complex environments where traditional rigid robots may be ineffective, while maintaining a reasonable degree of precision. Soft continuum manipulators have emerged as a growing subfield of continuum robotics, with promise for applications requiring high compliance, including certain medical procedures. This has driven demand for new control schemes designed to precisely control these highly flexible manipulators, whose kinematics may be sensitive to external loads, such as gravity. This article presents one such approach, utilizing a rapidly computed kinematic model based on Cosserat rod theory, coupled with sensor feedback to facilitate closed-loop control, for a soft continuum manipulator under tip follower actuation and external loading. This approach is suited to soft manipulators undergoing quasi-static deployment, where actuators apply a follower wrench (i.e., one that is in a constant body frame direction regardless of robot configuration) anywhere along the continuum structure, as can be done in water-jet propulsion. In this article we apply the framework specifically to a tip actuated soft continuum manipulator. The proposed control scheme employs both actuator feedback and pose feedback. The actuator feedback is utilized to both regulate the follower load and to compensate for non-linearities of the actuation system that can introduce kinematic model error. Pose feedback is required to maintain accurate path following. Experimental results demonstrate successful path following with the closed-loop control scheme, with significant performance improvements gained through the use of sensor feedback when compared with the open-loop case.

Feasibility of Fiber Reinforcement Within Magnetically Actuated Soft Continuum Robots.

Soft continuum manipulators have the potential to replace traditional surgical catheters; offering greater dexterity with access to previously unfeasible locations for a wide range of interventions including neurological and cardiovascular. Magnetically actuated catheters are of particular interest due to their potential for miniaturization and remote control. Challenges around the operation of these catheters exist however, and one of these occurs when the angle between the actuating field and the local magnetization vector of the catheter exceeds 90°. In this arrangement, deformation generated by the resultant magnetic moment acts to increase magnetic torque, leading to potential instability. This phenomenon can cause unpredictable responses to actuation, particularly for soft, flexible materials. When coupled with the inherent challenges of sensing and localization inside living tissue, this behavior represents a barrier to progress. In this feasibility study we propose and investigate the use of helical fiber reinforcement within magnetically actuated soft continuum manipulators. Using numerical simulation to explore the design space, we optimize fiber parameters to enhance the ratio of torsional to bending stiffness. Through bespoke fabrication of an optimized helix design we validate a single, prototypical two-segment, 40 mm × 6 mm continuum manipulator demonstrating a reduction of 67% in unwanted twisting under actuation.

An Origami-Based Soft Robotic Actuator for Upper Gastrointestinal Endoscopic Applications.

Soft pneumatic actuators have been explored for endoscopic applications, but challenges in fabricating complex geometry with desirable dimensions and compliance remain. The addition of an endoscopic camera or tool channel is generally not possible without significant change in the diameter of the actuator. Radial expansion and ballooning of actuator walls during bending is undesirable for endoscopic applications. The inclusion of strain limiting methods like, wound fibre, mesh, or multi-material molding have been explored, but the integration of these design approaches with endoscopic requirements drastically increases fabrication complexity, precluding reliable translation into functional endoscopes. For the first time in soft robotics, we present a multi-channel, single material elastomeric actuator with a fully corrugated design (inspired by origami); offering specific functionality for endoscopic applications. The features introduced in this design include i) fabrication of multi-channel monolithic structure of 8.5 mm diameter, ii) incorporation of the benefits of corrugated design in a single material (i.e., limited radial expansion and improved bending efficiency), iii) design scalability (length and diameter), and iv) incorporation of a central hollow channel for the inclusion of an endoscopic camera. Two variants of the actuator are fabricated which have different corrugated or origami length, i.e., 30 mm and 40 mm respectively). Each of the three actuator channels is evaluated under varying volumetric (0.5 mls-1 and 1.5 mls-1 feed rate) and pressurized control to achieve a similar bending profile with the maximum bending angle of 150°. With the intended use for single use upper gastrointestinal endoscopic application, it is desirable to have linear relationships between actuation and angular position in soft pneumatic actuators with high bending response at low pressures; this is where the origami actuator offers contribution. The soft pneumatic actuator has been demonstrated to achieve a maximum bending angle of 200° when integrated with manually driven endoscope. The simple 3-step fabrication technique produces a complex origami pattern in a soft robotic structure, which promotes low pressure bending through the opening of the corrugation while retaining a small diameter and a central lumen, required for successful endoscope integration.

Evolutionary Inverse Material Identification: Bespoke Characterization of Soft Materials Using a Metaheuristic Algorithm.

The growing interest in soft robotics has resulted in an increased demand for accurate and reliable material modelling. As soft robots experience high deformations, highly nonlinear behavior is possible. Several analytical models that are able to capture this nonlinear behavior have been proposed, however, accurately calibrating them for specific materials and applications can be challenging. Multiple experimental testbeds may be required for material characterization which can be expensive and cumbersome. In this work, we propose an alternative framework for parameter fitting established hyperelastic material models, with the aim of improving their utility in the modelling of soft continuum robots. We define a minimization problem to reduce fitting errors between a soft continuum robot deformed experimentally and its equivalent finite element simulation. The soft material is characterized using four commonly employed hyperelastic material models (Neo Hookean; Mooney-Rivlin; Yeoh; and Ogden). To meet the complexity of the defined problem, we use an evolutionary algorithm to navigate the search space and determine optimal parameters for a selected material model and a specific actuation method, naming this approach as Evolutionary Inverse Material Identification (EIMI). We test the proposed approach with a magnetically actuated soft robot by characterizing two polymers often employed in the field: Dragon Skin™ 10 MEDIUM and Ecoflex™ 00-50. To determine the goodness of the FEM simulation for a specific set of model parameters, we define a function that measures the distance between the mesh of the FEM simulation and the experimental data. Our characterization framework showed an improvement greater than 6% compared to conventional model fitting approaches at different strain ranges based on the benchmark defined. Furthermore, the low variability across the different models obtained using our approach demonstrates reduced dependence on model and strain-range selection, making it well suited to application-specific soft robot modelling.

A dual-bending endoscope with shape-lockable hydraulic actuation and water-jet propulsion for gastrointestinal tract screening.

BACKGROUND: Traditional flexible endoscopes are sophisticated medical devices that require frequent and expensive maintenance. Therefore, their implementation within low-income and rural regions is challenging due to their high cost, complex sterilization process and poor portability. AIMS: This paper aims to develop an endoscopic platform that is low-cost, disposable and portable, with the primary goal of reducing gastric cancer-related mortality among low- and middle-income communities through wider access to regular screening programs. MATERIALS AND METHODS: The endoscope employs a custom microvalve to switch between hydraulic actuation of a spatial bending fluidic actuator and water-jet actuation. Three alloy wires with buckle attachments are connected to a pneumatic balloon which facilitates reversible shape-locking of the actuator, and thus supports stable scanning by water-jet actuation. Distal tip of the device has an internal charge-coupled device camera for inspection. RESULTS: Experiments demonstrated a 58% increase in the workspace after introduction of the water-jet and more than three times the load-locking ability variation. Phantom experiment was also conducted for performance comparison with a traditional endoscope. CONCLUSION: By controlling the pressure of supplied water and the inflation of locking balloon, the endoscope achieves a satisfactory workspace and a remarkable shape-locking ability, demonstrating its potential clinical value in improving the prospects for upper gastrointestinal tract disease screening, especially gastric cancer.

A Compression Valve for Sanitary Control of Fluid-Driven Actuators.

With significant research focused on integrating robotics into medical devices, sanitary control of pressurizing fluids in a precise, accurate and customizable way is highly desirable. Current sanitary flow control methods include pinch valves which clamp the pressure line locally to restrict fluid flow; resulting in damage and variable flow characteristics over time. This paper presents a sanitary compression valve based on an eccentric clamping mechanism. The proposed valve distributes clamping forces over a larger area, thereby reducing the plastic deformation and associated influence on flow characteristic. Using the proposed valve, significant reductions in plastic deformation (up to 96%) and flow-rate error (up to 98%) were found, when compared with a standard pinch valve. Additionally, an optimization strategy presents a method for improving linearity and resolution over the working range to suit specific control applications. The valve efficacy has been evaluated through controlled testing of a water jet propelled low-cost endoscopic device. In this case, use of the optimized valve shows a reduction in the average orientation error and its variation, resulting in smoother movement of the endoscopic tip when compared to alternative wet and dry valve solutions. The presented valve offers a customizable solution for sanitary control of fluid driven actuators.

Online Disturbance Estimation for Improving Kinematic Accuracy in Continuum Manipulators.

Continuum manipulators are flexible robots which undergo continuous deformation as they are actuated. To describe the elastic deformation of such robots, kinematic models have been developed and successfully applied to a large variety of designs and to various levels of constitutive stiffness. Independent of the design, kinematic models need to be calibrated to best describe the deformation of the manipulator. However, even after calibration, unmodeled effects such as friction, nonlinear elastic and/or spatially varying material properties as well as manufacturing imprecision reduce the accuracy of these models. In this paper, we present a method for improving the accuracy of kinematic models of continuum manipulators through the incorporation of orientation sensor feedback. We achieve this through the use of a "disturbance wrench", which is used to compensate for these unmodeled effects, and is continuously estimated based on orientation sensor feedback as the robot moves through its workspace. The presented method is applied to the HydroJet, a waterjet-actuated soft continuum manipulator, and shows an average of 40% reduction in root mean square position and orientation error in the two most common types of kinematic models for continuum manipulators, a Cosserat rod model and a pseudo-rigid body model.

Parallel Helix Actuators for Soft Robotic Applications.

Fabrication of soft pneumatic bending actuators typically involves multiple steps to accommodate the formation of complex internal geometry and the alignment and bonding between soft and inextensible materials. The complexity of these processes intensifies when applied to multi-chamber and small-scale (~10 mm diameter) designs, resulting in poor repeatability. Designs regularly rely on combining multiple prefabricated single chamber actuators or are limited to simple (fixed cross-section) internal chamber geometry, which can result in excessive ballooning and reduced bending efficiency, compelling the addition of constraining materials. In this work, we address existing limitations by presenting a single material molding technique that uses parallel cores with helical features. We demonstrate that through specific orientation and alignment of these internal structures, small diameter actuators may be fabricated with complex internal geometry in a single material-without- additional design-critical steps. The helix design produces wall profiles that restrict radial expansion while allowing compact designs through chamber interlocking, and simplified demolding. We present and evaluate three-chambered designs with varied helical features, demonstrating appreciable bending angles (>180°), three-dimensional workspace coverage, and three-times bodyweight carrying capability. Through application and validation of the constant curvature assumption, forward kinematic models are presented for the actuator and calibrated to account for chamber-specific bending characteristics, resulting in a mean model tip error of 4.1 mm. This simple and inexpensive fabrication technique has potential to be scaled in size and chamber numbers, allowing for application-specific designs for soft, high-mobility actuators especially for surgical, or locomotion applications.

Dual-Continuum Design Approach for Intuitive and Low-Cost Upper Gastrointestinal Endoscopy.

OBJECTIVE: This paper introduces a methodology to design intuitive, low-cost, and portable devices for visual inspection of the upper gastrointestinal tract. METHODS: The proposed approach mechanically couples a multi-backbone continuum structure, as the user interface, and a parallel bellows actuator, as the endoscopic tip. Analytical modeling techniques derived from continuum robotics were adopted to describe the endoscopic tip motion from user input, accounting for variations in component size and pneumatic compressibility. The modeling framework was used to improve intuitiveness of user-to-task mapping. This was assessed against a 1:1 target, while ease-of-use was validated using landmark identification tasks performed in a stomach simulator by one expert and ten non-expert users; benchmarked against conventional flexible endoscopy. Pre-clinical validation consisted of comparative trials in in-vivo porcine and human cadaver models. RESULTS: Target mapping was achieved with an average error of 5° in bending angle. Simulated endoscopies were performed by an expert user successfully, within a time comparable to conventional endoscopy (<1 minute difference). Non-experts using the proposed device achieved visualization of the stomach in a shorter time (9s faster on average) than with a conventional endoscope. The estimated cost is <10 USD and <30 USD for disposable and reusable parts, respectively. Significance and Conclusions: Flexible endoscopes are complex and expensive devices, actuated via non-intuitive cable-driven mechanisms. They frequently break, requiring costly repair, and necessitate a dedicated reprocessing facility to prevent cross contamination. The proposed solution is portable, inexpensive, and easy to use, thus lending itself to disposable use by personnel without formal training in flexible endoscopy.

Real-Time Assessment of Mechanical Tissue Trauma in Surgery.

OBJECTIVE: This work presents a method to assess and prevent tissue trauma in real-time during surgery. BACKGROUND: Tissue trauma occurs routinely during laparoscopic surgery with potentially severe consequences. As such, it is crucial that a surgeon is able to regulate the pressure exerted by surgical instruments. We propose a novel method to assess the onset of tissue trauma by considering the mechanical response of tissue as it is loaded in real-time. METHODS: We conducted a parametric study using a lab-based grasping model and differing load conditions. Mechanical stress-time data were analyzed to characterize the tissue response to grasps. Qualitative and quantitative histological analyses were performed to inspect damage characteristics of the tissue under different load conditions. These were correlated against the mechanical measures to identify the nature of trauma onset with respect to our predictive metric. RESULTS: Results showed increasing tissue trauma with load and a strong correlation with the mechanical response of the tissue. Load rate and load history also showed a clear effect on tissue response. The proposed method for trauma assessment was effective in identifying damage. The metric can be normalized with respect to loading rate and history, making it feasible in the unconstrained environment of intraoperative surgery. SIGNIFICANCE: This work demonstrates that tissue trauma can be predicted using mechanical measures in real-time. Applying this technique to laparoscopic tools has the potential to reduce unnecessary tissue trauma and its associated complications by indicating through user feedback or actively regulating the mechanical impact of surgical instruments.

A novel multiple electrode direct current technique for characterisation of tissue resistance during surgery.

Electrochemical and electrical characteristics have the potential to help differentiate between, and assess the health state of, different biological tissues. However, measurement and interpretation of these characteristics is non-trivial. We propose a new DC galvanostatic sensing method for application to laparoscopic cancer surgery. This presents a simple and cost-effective measurement coupled with straightforward data interpretation. This paper describes the electrochemical and electrical theory underpinning the technique. Additionally, we describe a measurement system employing this technique and present an investigation into the feasibility of using it for measuring the resistance of different tissue types. Measurements were performed on ex vivo porcine liver, colon and rectum tissues. Outputs were consistent with theory and showed a significant difference between the resistance of the different tissue types, (one-way ANOVA, F(2, 28) = 1369, p <; 0.01). These findings indicate that this novel technique may be viable as a low cost method for the discrimination and health assessment of tissues in clinical scenarios.

Can virtual reality trainers improve the compliance discrimination abilities of trainee surgeons?

The assessment of tissue compliance using a handheld tool is an important skill in medical areas such as laparoscopic and dental surgery. The increasing prevalence of virtual reality devices raises the question of whether we can exploit these systems to accelerate the training of compliance discrimination in trainee surgeons. We used a haptic feedback device and stylus to assess the abilities of naïve participants to detect compliance differences with and without knowledge of results (KR) (groups 1 and 2), as well as the abilities of participants who had undergone repetitive training over several days (group 3). Kinematic analyses were carried out to objectively measure the probing action. Untrained participants had poor detection thresholds (mean just noticeable difference, JND = 33%), and we found no effect of KR (provided after each trial) on performance (mean JND = 35%). Intensive training dramatically improved group performance (mean JND = 12%). Probing action (in particular, slower movement execution) was associated with better detection thresholds, but training did not lead to systematic changes in probing behaviour. These findings set a benchmark for training systems that act to increase perceptual sensitivity and guide the learner toward optimal movement strategies to improve discrimination.