The RAIS Device for Global Surgery: Using a Participatory Design Approach to Navigate the Translational Pathway to Clinical Use.

BACKGROUND: Over 5 billion people worldwide have no access to surgery worldwide, typically in low-resource settings, despite it being a primary life-saving treatment. Gas Insufflation-Less Laparoscopic Surgery (GILLS) can address this inequity, by improving current GILLS instrumentation to modern surgical standards. OBJECTIVE: to develop and translate a new Retractor for Abdominal Insufflation-less Surgery (RAIS) into clinical use and thus provide a context-appropriate system to advance GILLS surgery. METHODS: A collaborative multidisciplinary team from the UK and India was formed, embedding local clinical stakeholders and an industry partner in defining user and contextual needs. System development was based on a phased roadmap for 'surgical device design in low resource settings' and embedded participatory and frugal design principles in an iterative process supported by traditional medical device design methodologies. Each phase of development was evaluated by the stakeholder team through interactive workshops using cadaveric surgical simulations. A Commercialisation phase undertook Design to Manufacture and regulatory approval activities. Clinical validation was then conducted with rural surgeons performing GILLS procedures using the RAIS system. Semi-structured questionnaires and interviews were used to evaluate device performance. RESULTS: A set of user needs and contextual requirements were defined and formalised. System development occurred across five iterations. Stakeholder participation was instrumental in converging on a design which met user requirements. A commercial RAIS system was then produced by an industry partner under Indian regulatory approval. This was successfully used in clinical validation to conduct 12 surgical procedures at two locations in rural India. Surgical feedback showed that the RAIS system provided a valuable and usable surgical instrument which was appropriate for use in low-resource contexts. CONCLUSIONS: Using a context-specific development approach with close engagement of stakeholders was crucial to develop the RAIS system for low-resource regions. The outcome is translation from global health need into a fully realized commercial instrument which can be used by surgeons in low-resource regions across India.

Hybrid position and orientation tracking for a passive rehabilitation table-top robot.

This paper presents a real time hybrid 2D position and orientation tracking system developed for an upper limb rehabilitation robot. Designed to work on a table-top, the robot is to enable home-based upper-limb rehabilitative exercise for stroke patients. Estimates of the robot's position are computed by fusing data from two tracking systems, each utilizing a different sensor type: laser optical sensors and a webcam. Two laser optical sensors are mounted on the underside of the robot and track the relative motion of the robot with respect to the surface on which it is placed. The webcam is positioned directly above the workspace, mounted on a fixed stand, and tracks the robot's position with respect to a fixed coordinate system. The optical sensors sample the position data at a higher frequency than the webcam, and a position and orientation fusion scheme is proposed to fuse the data from the two tracking systems. The proposed fusion scheme is validated through an experimental set-up whereby the rehabilitation robot is moved by a humanoid robotic arm replicating previously recorded movements of a stroke patient. The results prove that the presented hybrid position tracking system can track the position and orientation with greater accuracy than the webcam or optical sensors alone. The results also confirm that the developed system is capable of tracking recovery trends during rehabilitation therapy.

The impact of electrode resistance on the biogalvanic characterisation technique.

Measurement of a tissue-specific electrical resistance may offer a discriminatory metric for evaluation of tissue health during cancer surgery. With a move toward minimally-invasive procedures, applicable contact sensing modalities must be scalable, fast and robust. A passive resistance characterisation method utilising a biogalvanic cell as an intrinsic power source has been proposed as a potentially suitable solution. Previous work has evaluated this system with results showing effective discrimination of tissue type and damage (through electroporation). However, aspects of the biogalvanic cell have been found to influence the characterisation performance, and are not currently accounted for within the system model. In particular, the electrode and salt-bridge resistance are not independently determined, leading to over-predictions of tissue resistivity. This paper describes a more comprehensive model and characterisation scheme, with electrode parameters and salt-bridge resistivity being evaluated independently. In a generalised form, the presented model illustrates how the relative resistive contributions from the electrodes and medium relate to the existing characterisation method efficacy. We also describe experiments with physiologically relevant salt solutions (1.71, 17.1, 154 mM), used for validation and comparison. The presented model shows improved performance over the current biogalvanic measurement technique at the median conductivity. Both the proposed and extant system models become unable to predict conductivity accurately at high conductivity due to the dominance of the electrodes. The characterisation techniques have also been applied to data collected on freshly excised human colon tissue (healthy and cancerous). The findings suggest that the resistance of the cell under the test conditions is electrode dominated, leading to erroneous tissue resistance determination. Measurement optimisation strategies and the surgical applicability of the biogalvanic technique are discussed in light of these findings.

A time-dependent model for improved biogalvanic tissue characterisation.

Measurement of the passive electrical resistance of biological tissues through biogalvanic characterisation has been proposed as a simple means of distinguishing healthy from diseased tissue. This method has the potential to provide valuable real-time information when integrated into surgical tools. Characterised tissue resistance values have been shown to be particularly sensitive to external load switching direction and rate, bringing into question the stability and efficacy of the technique. These errors are due to transient variations observed in measurement data that are not accounted for in current electrical models. The presented research proposes the addition of a time-dependent element to the characterisation model to account for losses associated with this transient behaviour. Influence of switching rate has been examined, with the inclusion of transient elements improving the repeatability of the characterised tissue resistance. Application of this model to repeat biogalvanic measurements on a single ex vivo human colon tissue sample with healthy and cancerous (adenocarcinoma) regions showed a statistically significant difference (p < 0.05) between tissue types. In contrast, an insignificant difference (p > 0.05) between tissue types was found when measurements were subjected to the current model, suggesting that the proposed model may allow for improved biogalvanic tissue characterisation.

Assessment of electrochemical properties of a biogalvanic system for tissue characterisation.

Biogalvanic characterisation is a promising method for obtaining health-specific tissue information. However, there is a dearth of understanding in the literature regarding the underlying galvanic cell, electrode reactions and their controlling factors which limits the application of the technique. This work presents a parametric electrochemical investigation into a zinc­copper galvanic system using salt (NaCl) solution analogues at physiologically-relevant concentrations (1.71, 17.1 & 154 mM). The potential difference at open cell, closed cell maximum current and the internal resistance (based on published characterisation methods) were measured. Additionally, independent and relative polarisation scans of the electrodes were performed to improve understanding of the system. Our findings suggest that the prominent reaction at the cathode is that of oxygen-reduction, not hydrogen-evolution. Results indicate that cell potentials are influenced by the concentration of dissolved oxygen at low currents and maximum closed cell currents are limited by the rate of oxygen diffusion to the cathode. Characterised internal resistance values for the salt solutions did not correspond to theoretical values at the extremes of concentration (1.71 and 154 mM) due to electrode resistance and current limitation. Existing biogalvanic models do not consider these phenomena and should be improved to advance the technique and its practical application.

Technological assessment of the biogalvanic method for tissue characterization.

Biogalvanic cells have the potential to be used in characterizing biological tissue properties and ultimately tissue health. A biogalvanic cell is established by placing two differing metal electrodes across a target tissue allowing an electrical tissue-specific internal resistance to be determined. A novel data analysis method using least-squares fitting has been developed to more effectively determine the parameters of the biogalvanic system model proposed in the literature. The validity of the method has been examined through characterization of electrical models, ex vivo porcine tissue, and in vivo porcine tissue. Strong agreement between test results and the proposed characterization model has been shown. However, determined internal resistances are influenced by mechanical strain, current modulation direction and tissue thickness, indicating complexities at the electrode­tissue interface. These complexities undermine some assumptions upon which the biogalvanic model is based. Ultimately this technique could offer potential for use in minimally invasive surgery for discriminating tissue health but requires improved understanding and control of testing conditions.

Robotic platforms for general and colorectal surgery.

Surgeons are increasingly turning to new technologies to help them overcome the barriers imposed by minimally invasive surgery (MIS). Robotics is an enabling technology with obvious applications to MIS. This manuscript looks at robotic platforms for general surgical application and explores the advantages, limitations and possible future roles.

A novel robotic system for quantifying arm kinematics and kinetics: description and evaluation in therapist-assisted passive arm movements post-stroke.

We developed a system for quantitatively measuring arm movement. Our approach provides a method to simultaneously capture upper limb kinetic and kinematic data during assisted passive arm movements. Data are analysed with respect to Cartesian and upper limb coordinate systems to obtain upper limb joint angles and torques. We undertook an evaluation of the system in participants with stroke to show the feasibility of this approach. During rehabilitation after stroke, one aspect of treatment includes the physiotherapist applying assistive forces to move the impaired arm of the patient who remains passive. There is a dearth of published data on the relationship between upper limb kinematics and the underlying forces (kinetics) in this mode of physiotherapy treatment. Such quantitative data are crucial in facilitating research into therapy practice, for example by measuring variation in practice and determining dosage. An experienced therapist prescribed passive movements tailored to the needs of 16 participants with stroke (41-81 years) with a range of anthropometric sizes and motor impairments. Our novel measurement tool recorded kinematic and kinetic data at 100 Hz for 6-11 movements per participant. The kinetic data show that the majority of movements fall within upper limits of 36.7 N in shoulder elevation, 22.4N in shoulder protraction, 4.6 Nm in shoulder abduction, 12.8 Nm in shoulder flexion, 2.4 Nm in shoulder rotation and 5.5 Nm in elbow flexion. These data show the potential of this system to better understand arm movement, in particular to objectively evaluate physical therapy treatments and support development of robotic devices to facilitate upper limb rehabilitation.

Effector force requirements to enable robotic systems to provide assisted exercise in people with upper limb impairment after stroke.

iPAM (intelligent Pneumatic Arm Movement) is a dual robotic system that aims to assist in the recovery of upper-limb movement in people with all severities of motor impairment after stroke. This paper presents effector force data gathered during the course of a pilot clinical study. It identifies the forces and workspace required to facilitate reach-retrieve exercises in a range of patients as part of rehabilitation treatments. These findings have been used in further refinements of the iPAM system.