Towards inferring positioning of straight cochlear-implant electrode arrays during insertion using real-time impedance sensing.

BACKGROUND: Cochlear-implant electrode arrays (EAs) are currently inserted with limited feedback, and impedance sensing has recently shown promise for EA localisation. METHODS: We investigate the use of impedance sensing to infer the progression of an EA during insertion. RESULTS: We show that the access resistance component of bipolar impedance sensing can detect when a straight EA reaches key anatomical locations in a plastic cochlea and when each electrode contact enters/exits the cochlea. We also demonstrate that dual-sided electrode contacts can provide useful proximity information and show the real-time relationship between impedance and wall proximity in a cadaveric cochlea for the first time. CONCLUSION: The access resistance component of bipolar impedance sensing has high potential for estimating positioning information of EAs relative to anatomy during insertion. Main limitations of this work include using saline as a surrogate for human perilymph in ex vivo models and using only one type of EA.

Dynamic Behavior and Insertional Forces of a Precurved Electrode Using the Pull-Back Technique in a Fresh Microdissected Cochlea.

HYPOTHESIS: This study evaluated the utility of the pull-back technique in improving perimodiolar positioning of a precurved cochlear implant (CI) electrode array (EA) with simultaneous insertion force profile measurement and direct observation of dynamic EA behavior. BACKGROUND: Precurved EAs with perimodiolar positioning have improved outcomes compared with straight EAs because of lowered charge requirements for stimulation and decreased spread of excitation. The safety and efficacy of the pull-back technique in further improving perimodiolar positioning and its associated force profile have not been adequately demonstrated. METHODS: The bone overlying the scala vestibuli was removed in 15 fresh cadaveric temporal bones, leaving the scala tympani unviolated. Robotic insertions of EAs were performed with simultaneous force measurement and video recording. Force profiles were obtained during standard insertion, overinsertion, and pull-back. Postinsertion CT scans were obtained during each of the three conditions, enabling automatic segmentation and calculation of angular insertion depth, mean perimodiolar distance ( Mavg ), and cochlear duct length. RESULTS: Overinsertion did not result in significantly higher peak forces than standard insertion (mean [SD], 0.18 [0.06] and 0.14 [0.08] N; p = 0.18). Six temporal bones (40%) demonstrated visibly improved perimodiolar positioning after the protocol, whereas none worsened. Mavg significantly improved after the pull-back technique compared with standard insertion (mean [SD], 0.34 [0.07] and 0.41 [0.10] mm; p < 0.01). CONCLUSIONS: The pull-back technique was not associated with significantly higher insertional forces compared with standard insertion. This technique was associated with significant improvement in perimodiolar positioning, both visually and quantitatively, independent of cochlear size.

Robotic pullback technique of a precurved cochlear-implant electrode array using real-time impedance sensing feedback.

PURPOSE: During traditional insertion of cochlear implant (CI) electrode arrays (EAs), surgeons rely on limited tactile feedback and visualization of the EA entering the cochlea to control the insertion. One insertion approach for precurved EAs involves slightly overinserting the EA and then retracting it slightly to achieve closer hugging of the modiolus. In this work, we investigate whether electrical impedance sensing could be a valuable real-time feedback tool to advise this pullback technique. METHODS: Using a to-scale 3D-printed scala tympani model, a robotic insertion tool, and a custom impedance sensing system, we performed experiments to assess the bipolar insertion impedance profiles for a cochlear CI532/632 precurved EA. Four pairs of contacts from the 22 electrode contacts were chosen based on preliminary testing and monitored in real time to halt the robotic insertion once the closest modiolar position had been achieved but prior to when the angular insertion depth (AID) would be reduced. RESULTS: In this setting, the open-loop robotic insertion impedance profiles were very consistent between trials. The exit of each contact from the external stylet of this EA was clearly discernible on the impedance profile. In closed-loop experiments using the pullback technique, the average distance from the electrode contacts to the modiolus was reduced without greatly affecting the AID by using impedance feedback in real time to determine when to stop EA retraction. CONCLUSION: Impedance sensing, and specifically the access resistance component of impedance, could be a valuable real-time feedback tool in the operating room during CI EA insertion. Future work should more thoroughly analyze the effects of more realistic operating room conditions and inter-patient variability on this technique.

Real-Time Localization of Cochlear-Implant Electrode Arrays Using Bipolar Impedance Sensing.

OBJECTIVE: Surgeons have no direct objective feedback on cochlear-implant electrode array (EA) positioning during insertion, yet optimal hearing outcomes are contingent on placing the EA as close as feasible to viable neural endings. This paper describes a system to non-invasively determine intracochlear positioning of an EA, without requiring any modifications to existing commercial EAs themselves. METHODS: Electrical impedance has been suggested as a way to measure EA proximity to the inner wall of the cochlea that houses auditory nerve endings-the modiolus. In this paper, we extend prior work and demonstrate for the first time the relationship between bipolar access resistance and proximity of the EA to the modiolus (E-M proximity). We also evaluate two methods for producing direct, real-time estimates of E-M proximity from bipolar impedance measurements. RESULTS: We show that bipolar access resistance is highly correlated with E-M proximity and can be approximately modeled by a power law function. This one dimensional model is shown to be capable of producing accurate real-time estimates of E-M proximity, but its simplicity also limits the potential for future improvement. To address this challenge, we propose a new prediction approach based on a recurrent neural network, which generated an overall prediction accuracy of 93.7%. CONCLUSION: Bipolar access resistance is highly correlated with E-M proximity, and can be used to estimate EA positioning. SIGNIFICANCE: This work shows how impedance sensing can be used to localize an EA during insertion into the small, enclosed cochlear environment, without requiring any modifications to existing clinically used EAs.

Clinical Translation of an Insertion Tool for Minimally Invasive Cochlear Implant Surgery.

The objective of this paper is to describe the development of a minimally invasive cochlear implant surgery (MICIS) electrode array insertion tool concept to enable clinical translation. First, analysis of the geometric parameters of potential MICIS patients (N = 97) was performed to inform tool design, inform MICIS phantom model design, and provide further insight into MICIS candidacy. Design changes were made to the insertion tool based on clinical requirements and parameter analysis results. A MICIS phantom testing model was built to evaluate insertion force profiles in a clinically realistic manner, and the new tool design was evaluated in the model and in cadavers to test clinical viability. Finally, after regulatory approval, the tool was used for the first time in a clinical case. Results of this work included first, in the parameter analysis, approximately 20% of the population was not considered viable MICIS candidates. Additionally, one 3D printed tool could accommodate all viable candidates with polyimide sheath length adjustments accounting for interpatient variation. The insertion tool design was miniaturized out of clinical necessity and a disassembly method, necessary for removal around the cochlear implant, was developed and tested. Phantom model testing revealed that the force profile of the insertion tool was similar to that of traditional forceps insertion. Cadaver testing demonstrated that all clinical requirements (including complete disassembly) were achieved with the tool, and the new tool enabled 15% deeper insertions compared to the forceps approach. Finally, and most importantly, the tool helped achieve a full insertion in its first MICIS clinical case. In conclusion, the new insertion tool provides a clinically viable solution to one of the most difficult aspects of MICIS.

Magnetic Steering of Robotically Inserted Lateral-wall Cochlear-implant Electrode Arrays Reduces Forces on the Basilar Membrane In Vitro.

HYPOTHESIS: Undesirable forces applied to the basilar membrane during surgical insertion of lateral-wall cochlear-implant electrode arrays (EAs) can be reduced via robotic insertion with magnetic steering of the EA tip. BACKGROUND: Robotic insertion of magnetically steered lateral-wall EAs has been shown to reduce insertion forces in vitro and in cadavers. No previous study of robot-assisted insertion has considered force on the basilar membrane. METHODS: Insertions were executed in an open-channel scala-tympani phantom. A force plate, representing the basilar membrane, covered the channel to measure forces in the direction of the basilar membrane. An electromagnetic source generated a magnetic field to steer investigational EAs with permanent magnets at their tips, while a robot performed the insertion. RESULTS: When magnetic steering was sufficient to pull the tip of the EA off of the lateral wall of the channel, it resulted in at least a 62% reduction of force on the phantom basilar membrane at insertion depths beyond 14.4 mm (p < 0.05), and these beneficial effects were maintained beyond approximately the same depth, even with 10 degrees of error in the estimation of the modiolar axis of the cochlea. When magnetic steering was not sufficient to pull the EA tip off of the lateral wall, a significant difference from the no-magnetic-steering case was not found. CONCLUSIONS: This in vitro study suggests that magnetic steering of robotically inserted lateral-wall cochlear-implant EAs, given sufficient steering magnitude, can reduce forces on the basilar membrane in the first basilar turn compared with robotic insertion without magnetic steering.

Robotic Ear Surgery.

Robots under research and development for otology can be classified as collaborative (intervention is constrained by the robot but surgeon directly actuates the end-effector), teleoperated (surgeon remotely controls a tool with modification [eg, tremor reduction] by the robot), or autonomous (surgeon monitors the robot performing a task). Current clinical trials focus on more accurate stapes surgery, minimally invasive access to the cochlea, and less traumatic insertion of cochlear implant electrode arrays. Autonomous approaches to major aspects of surgical interventions (eg, mastoidectomy) will likely be late entries to clinical use, given higher cost of regulatory approval and disruption of existing workflow.

Custom mastoid-fitting templates to improve cochlear implant electrode insertion trajectory.

PURPOSE: Insertion trajectory affects final intracochlear cochlear implant (CI) positioning, but limited information is available intraoperatively regarding ideal trajectory. We sought to improve intracochlear positioning CI electrodes using custom templates to specify insertion trajectory. METHODS: 3D reconstructions were created from computed tomography of three cadaveric temporal bones. Trajectories co-planar with the straight segment of the cochlea's basal turn were considered ideal. Templates were designed to fit against the drilled mastoid's surface and convey this guided trajectory via a hollow cylinder. Templates were 3D-printed using stereolithography. Mastoidectomy was performed. Template accuracy was tested by measuring target registration error (TRE) for four templates. A novel, roller-based insertion tool (designed to fit within the template cylinder) constrained insertions to intended trajectories. Insertions were performed with MED-EL Standard electrodes in three bones with three conditions: guided trajectory with insertion tool, non-guided trajectory with insertion tool and guided trajectory with surgical forceps. For the final condition, the template was used to mark the mastoid to convey trajectory. Insertion was stopped when electrode buckling occurred. RESULTS: TRE ranged from 0.23 to 0.73 mm. Mean TRE ± standard deviation was 0.55 ± 0.19 mm. Insertions along guided versus non-guided trajectories averaged more intracochlear electrodes (9, 8, 8 vs. 7, 7, 8) and greater angular insertion depths (AID) (377°, 341°, 320° vs. 278°, 302°, 290°). Insertions performed with forceps using templates as a guide also achieved excellent results (intracochlear electrodes: 10, 7, 8; AID: 478°, 318°, 333°). No translocations occurred. CONCLUSION: Custom mastoid-fitting templates reliably specify intended insertion trajectory and provide sufficient information for recreation of that trajectory with manual insertion after template removal. The templates can accurately target structures within the temporal bone with a TRE of 0.55 ± 0.19 mm. Our roller-based insertion tool achieves results comparable to manual insertion using surgical forceps.

Magnetically Steered Robotic Insertion of Cochlear-Implant Electrode Arrays: System Integration and First-In-Cadaver Results.

Cochlear-implant electrode arrays (EAs) must be inserted accurately and precisely to avoid damaging the delicate anatomical structures of the inner ear. It has previously been shown on the benchtop that using magnetic fields to steer magnet-tipped EAs during insertion reduces insertion forces, which correlate with insertion errors and damage to internal cochlear structures. This paper presents several advancements toward the goal of deploying magnetic steering of cochlear-implant EAs in the operating room. In particular, we integrate image guidance with patient-specific insertion vectors, we incorporate a new nonmagnetic insertion tool, and we use an electromagnetic source, which provides programmable control over the generated field. The electromagnet is safer than prior permanent-magnet approaches in two ways: it eliminates motion of the field source relative to the patient's head and creates a field-free source in the power-off state. Using this system, we demonstrate system feasibility by magnetically steering EAs into a cadaver cochlea for the first time. We show that magnetic steering decreases average insertion forces, in comparison to manual insertions and to image-guided robotic insertions alone.

A Dynamic Model for Concentric Tube Robots.

Existing static and kinematic models of concentric tube robots are based on the ordinary differential equations of a static Cosserat rod. In this paper, we provide the first dynamic model for concentric tube continuum robots by adapting the partial differential equations of a dynamic Cosserat rod to describe the coupled inertial dynamics of precurved concentric tubes. This generates an initial-boundary-value problem that can capture robot vibrations over time. We solve this model numerically at high time resolutions using implicit finite differences in time and arc length. This approach is capable of resolving the high-frequency torsional dynamics that occur during unstable "snapping" motions and provides a simulation tool that can track the true robot configuration through such transitions. Further, it can track slower oscillations associated with bending and torsion as a robot interacts with tissue at real-time speeds. Experimental verification of the model shows that this wide range of effects is captured efficiently and accurately.

A Hand-Held Non-Robotic Surgical Tool With a Wrist and an Elbow.

OBJECTIVE: This paper describes a surgical device that provides both wrist and elbow dexterity without motors or electronics. The device provides dexterity advantages in minimally invasive surgery typically associated with robotic systems, but does so with many fewer components. Fully mechanical designs of this type promise to deliver "robot-like dexterity" at a lower financial cost than current surgical robotic systems. METHODS: Most non-robotic articulated surgical tools developed to date feature one or two degrees-of-freedom (DOF) close to the tool tip (i.e., a "wrist"). In this paper, we describe a new tool that not only features a two-DOF wrist, but also augments its dexterity with a two-DOF "elbow" consisting of a multi-backbone design seen previously only in robotic systems. Such an elbow offers high stiffness in a thin form factor. This elbow requires static balancing, which we accomplish with springs in the handle, so that the surgeon can benefit from the stiffness without feeling it while using the device. RESULTS: We report the overall tool design and experiments evaluating how well our static balance mechanism compensates for the multi-backbone elbow's intrinsic stiffness. CONCLUSION: We demonstrate the use of a multi-backbone elbow in a manual tool for the first time and show how to combine the elbow with a pin joint wrist in a fully mechanical (i.e., non-robotic) tool. SIGNIFICANCE: This paper is a step toward high dexterity, low-cost surgical instruments that bring some benefits of surgical robotic systems to patients and surgeons at a lower cost.

Can Elastic Instability be Beneficial in Concentric Tube Robots?

Concentric tube manipulators exhibit elastic instability in which tubes snap from one configuration to another, rapidly releasing stored strain energy. While this has long been viewed as a negative phenomenon to be avoided at all costs, in this paper we explore for the first time whether the effect can be harnessed beneficially for certain applications. Specifically, we show that the energy released in an instability can be useful for challenging, high-force surgical tasks such as driving a needle through tissue. We use concentric tube models to define the energy released during elastic instability and experimentally evaluate a two-tube concentric manipulator that can drive suture needles through tissue by harnessing elastic instability beneficially.