Impact of Insertion Speed, Depth, and Robotic Assistance on Cochlear Implant Insertion Forces and Intracochlear Pressure: A Scoping Review.

Cochlear implants are crucial for addressing severe-to-profound hearing loss, with the success of the procedure requiring careful electrode placement. This scoping review synthesizes the findings from 125 studies examining the factors influencing insertion forces (IFs) and intracochlear pressure (IP), which are crucial for optimizing implantation techniques and enhancing patient outcomes. The review highlights the impact of variables, including insertion depth, speed, and the use of robotic assistance on IFs and IP. Results indicate that higher insertion speeds generally increase IFs and IP in artificial models, a pattern not consistently observed in cadaveric studies due to variations in methodology and sample size. The study also explores the observed minimal impact of robotic assistance on reducing IFs compared to manual methods. Importantly, this review underscores the need for a standardized approach in cochlear implant research to address inconsistencies and improve clinical practices aimed at preserving hearing during implantation.

First clinical implementation of insertion force measurement in cochlear implantation surgery.

Purpose: The significance of atraumatic electrode array (EA) insertion in cochlear implant (CI) surgery is widely acknowledged, with consensus that forces due to EA insertion are directly correlated with insertion trauma. Unfortunately, the manual perception of these forces through haptic feedback is inherently limited, and techniques for in vivo force measurements to monitor the insertion are not yet available. Addressing this gap, we developed of a force-sensitive insertion tool capable of capturing real-time insertion forces during standard CI surgery. Methods: This paper describes the tool and its pioneering application in a clinical setting and reports initial findings from an ongoing clinical study. Data and experiences from five patients have been evaluated so far, including force profiles of four patients. Results: The initial intraoperative experiences are promising, with successful integration into the conventional workflow. Feasibility of in vivo insertion force measurement and practicability of the tool's intraoperative use could be demonstrated. The recorded in vivo insertion forces show the expected rise with increasing insertion depth. Forces at the end of insertion range from 17.2 mN to 43.6 mN, while maximal peak forces were observed in the range from 44.8 mN to 102.4 mN. Conclusion: We hypothesize that this novel method holds the potential to assist surgeons in monitoring the insertion forces and, thus, minimizing insertion trauma and ensuring better preservation of residual hearing. Future data recording with this tool can form the basis of ongoing research into the causes of insertion trauma, paving the way for new and improved prevention strategies.

A study on modeling the deflection of surgical needle during insertion into multilayer tissues.

The use of subcutaneous and percutaneous needle and catheter insertions is standard in modern clinical practice. However, a common issue with bevel tip surgical needles is their tendency to deflect, causing them to miss the intended target inside the tissue. This study aims to understand the interaction between the needle and soft tissue and develop a model to predict the deflection of a bevel tip needle during insertion into multi-layered soft tissues. The study examined the mechanics of needle-tissue interaction and modeled the forces involved during insertion. The force model includes cutting force, deformation force, and friction between the needle and tissue. There was an 8%-23% difference between the total analytical and experimental force measurements. A modified Euler-Bernoulli beam elastic foundation theory was used to create an analytical model to predict the needle tip deflection in soft tissue. To validate the results, the analytical deflection model was then compared to the deflection from needle insertion experiments on multi-layered phantom tissues, showing a 9%-21% error between the two. While there is a slight discrepancy between the analytical and experimental results, the study shows that the proposed model can accurately predict needle tip deflection during insertion.

Preclinical evaluation of a tool for insertion force measurements in cochlear implant surgery.

PURPOSE: Trauma that may be inflicted to the inner ear (cochlea) during the insertion of an electrode array (EA) in cochlear implant (CI) surgery can significantly decrease the hearing outcome of patients with residual hearing. Interaction forces between the EA and the cochlea are a promising indicator for the likelihood of intracochlear trauma. However, insertion forces have only been measured in laboratory setups. We recently developed a tool to measure the insertion force during CI surgery. Here, we present the first ex vivo evaluation of our tool with a focus on usability in the standard surgical workflow. METHODS: Two CI surgeons inserted commercially available EAs into three temporal bone specimens. The insertion force and the orientation of the tool were recorded together with camera footage. The surgeons answered a questionnaire after each insertion to evaluate the surgical workflow with respect to CI surgery. RESULTS: The EA insertion using our tool was rated successful in all 18 trials. The surgical workflow was evaluated to be equivalent to standard CI surgery. Minor handling challenges can be overcome through surgeon training. The peak insertion forces were 62.4 mN ± 26.7 mN on average. Peak forces significantly correlated to the final electrode insertion depth, supporting the assumption that the measured forces mainly correspond to intracochlear events and not extracochlear friction. Gravity-induced forces of up to 28.8 mN were removed from the signal, illustrating the importance of the compensation of such forces in manual surgery. CONCLUSION: The results show that the tool is ready for intraoperative use. In vivo insertion force data will improve the interpretability of experimental results in laboratory settings. The implementation of live insertion force feedback to surgeons could further improve residual hearing preservation.

Impact of Scala Tympani Geometry on Insertion Forces during Implantation.

(1) Background: During a cochlear implant insertion, the mechanical trauma can cause residual hearing loss in up to half of implantations. The forces on the cochlea during the insertion can lead to this mechanical trauma but can be highly variable between subjects which is thought to be due to differing anatomy, namely of the scala tympani. This study presents a systematic investigation of the influence of different geometrical parameters of the scala tympani on the cochlear implant insertion force. The influence of these parameters on the insertion forces were determined by testing the forces within 3D-printed, optically transparent models of the scala tympani with geometric alterations. (2) Methods: Three-dimensional segmentations of the cochlea were characterised using a custom MATLAB script which parametrised the scala tympani model, procedurally altered the key shape parameters (e.g., the volume, vertical trajectory, curvature, and cross-sectional area), and generated 3D printable models that were printed using a digital light processing 3D printer. The printed models were then attached to a custom insertion setup that measured the insertion forces on the cochlear implant and the scala tympani model during a controlled robotic insertion. (3) Results: It was determined that the insertion force is largely unaffected by the overall size, curvature, vertical trajectory, and cross-sectional area once the forces were normalised to an angular insertion depth. A Capstan-based model of the CI insertion forces was developed and matched well to the data acquired. (4) Conclusion: By using accurate 3D-printed models of the scala tympani with geometrical alterations, it was possible to demonstrate the insensitivity of the insertion forces to the size and shape of the scala tympani, after controlling for the angular insertion depth. This supports the Capstan model of the cochlear implant insertion force which predicts an exponential growth of the frictional force with an angular insertion depth. This concludes that the angular insertion depth, rather than the length of the CI inserted, should be the major consideration when evaluating the insertion force and associated mechanical trauma caused by cochlear implant insertion.

Profound alterations in brain tissue linked to hypoxic episode after device implantation.

To enable authentic interfacing with neuronal structures in the brain, preventing alterations of tissue during implantation of devices is critical. By transiently implanting oxygen microsensors into rat cortex cerebri for 2 h, substantial and long lasting (>1 h) hypoxia is routinely generated in surrounding tissues; this hypoxia is linked to implantation generated compressive forces. Preferential loss of larger neurons and reduced metabolic components in surviving neurons indicates decreased viability one week after such hypoxic, compressive implantations. By devising an implantation method that relaxes compressive forces; magnitude and duration of hypoxia generated following such an implantation are ameliorated and neurons appear similar to naïve tissues. In line with these observations, astrocyte proliferation was significantly more pronounced for more hypoxic, compressive implantations. Surprisingly, astrocyte processes were frequently found to traverse cellular boundaries into nearby neuronal nuclei, indicating injury induction of a previously not described astrocyte-neuron interaction. Found more frequently in less hypoxic, force-relaxed insertions and thus correlating to a more beneficial outcome, this finding may suggest a novel protective mechanism. In conclusion, substantial and long lasting insertion induced hypoxia around brain implants, a previously overlooked factor, is linked to significant adverse alterations in nervous tissue.

Insertion forces and intracochlear trauma in temporal bone specimens implanted with a straight atraumatic electrode array.

The aim of the study was to evaluate insertion forces during manual insertion of a straight atraumatic electrode in human temporal bones, and post-implantation histologic evaluation of the samples to determine whether violation of intracochlear structures is related to insertion forces. In order to minimize intracochlear trauma and preserve residual hearing during cochlear implantation, knowledge of the insertion forces is necessary. Ten fresh frozen human temporal bones were prepared with canal wall down mastoidectomy. All samples were mounted on a one-axis force sensor. Insertion of a 16-mm straight atraumatic electrode was performed from different angles to induce "traumatic" insertion. Histologic evaluation was performed in order to evaluate intracochlear trauma. In 4 of 10 samples, dislocation of the electrode into scala vestibuli was observed. The mean insertion force for all 10 procedures was 0.003 ± 0.005 N. Insertion forces measured around the site of dislocation to scala vestibuli in 3 of 4 samples were significantly higher than insertion forces at the same location of the cochleae measured in samples without trauma (p < 0.04). Mean force during the whole insertion process of the straight atraumatic electrode is lower than reported by other studies using longer electrodes. Based on our study, insertion forces leading to basilar membrane trauma may be lower than the previously reported direct rupture forces.

Role of uterine forces in intrauterine device embedment, perforation, and expulsion.

BACKGROUND: The purpose of this study was to examine factors that could help reduce primary perforation during insertion of a framed intrauterine device (IUD) and to determine factors that contribute in generating enough uterine muscle force to cause embedment and secondary perforation of an IUD. The objective was also to evaluate the main underlying mechanism of IUD expulsion. METHODS: We compared known IUD insertion forces for "framed" devices with known perforation forces in vitro (hysterectomy specimens) and known IUD removal forces and calculated a range of possible intrauterine forces using pressure and surface area. These were compared with known perforation forces. RESULTS: IUD insertion forces range from 1.5 N to 6.5 N. Removal forces range from 1 N to 5.8 N and fracture forces from 8.7 N to 30 N depending upon device. Measured perforation forces are from 20 N to 54 N, and calculations show the uterus is capable of generating up to 50 N of myometrial force depending on internal pressure and surface area. CONCLUSION: Primary perforation with conventional framed IUDs may occur if the insertion pressure exceeds the perforation resistance of the uterine fundus. This is more likely to occur if the front end of the inserter/IUD is narrow, the passage through the cervix is difficult, and the procedure is complex. IUD embedment and secondary perforation and IUD expulsion may be due to imbalance between the size of the IUD and that of the uterine cavity, causing production of asymmetrical uterine forces. The uterine muscle seems capable of generating enough force to cause an IUD to perforate the myometrium provided it is applied asymmetrically. A physical theory for IUD expulsion and secondary IUD perforation is given.

Forces and trauma associated with minimally invasive image-guided cochlear implantation.

OBJECTIVE: Minimally invasive image-guided cochlear implantation (CI) utilizes a patient-customized microstereotactic frame to access the cochlea via a single drill-pass. We investigate the average force and trauma associated with the insertion of lateral wall CI electrodes using this technique. STUDY DESIGN: Assessment using cadaveric temporal bones. SETTING: Laboratory setup. SUBJECTS AND METHODS: Microstereotactic frames for 6 fresh cadaveric temporal bones were built using CT scans to determine an optimal drill path following which drilling was performed. CI electrodes were inserted using surgical forceps to manually advance the CI electrode array, via the drilled tunnel, into the cochlea. Forces were recorded using a 6-axis load sensor placed under the temporal bone during the insertion of lateral wall electrode arrays (2 each of Nucleus CI422, MED-EL standard, and modified MED-EL electrodes with stiffeners). Tissue histology was performed by microdissection of the otic capsule and apical photo documentation of electrode position and intracochlear tissue. RESULTS: After drilling, CT scanning demonstrated successful access to cochlea in all 6 bones. Average insertion forces ranged from 0.009 to 0.078 N. Peak forces were in the range of 0.056 to 0.469 N. Tissue histology showed complete scala tympani insertion in 5 specimens and scala vestibuli insertion in the remaining specimen with depth of insertion ranging from 360° to 600°. No intracochlear trauma was identified. CONCLUSION: The use of lateral wall electrodes with the minimally invasive image-guided CI approach was associated with insertion forces comparable to traditional CI surgery. Deep insertions were obtained without identifiable trauma.