A software for online monitoring of orientation-compensated forces during CI insertion

The electrode array insertion is a critical point during CI surgery and should be performed as gently as possible to preserve residual hearing. In order to measure occurring forces, an insertion tool with an integrated force sensor and an inertial measurement unit (IM U) is being developed. The weight of the electrode holder and the sensor add an unknown offset to the measured forces, depending on the tool orientation. To address this problem, a software which calculates the orientation-induced error and computes a corrected force was developed. The software was written in C++ using the library Qt 5.12.9. For maximization of the computing frequency, the data acquisition of both sensors and the monitoring was parallelized. An algorithm was developed to calculate the error caused by the electrode holder and sensor. For this purpose both weights were determined in a calibration procedure and merged with the provided IM U data. The evaluation was done in two test series (each n=5) with different initial tool orientations. To this end a stepwise 360° rotation around the horizontal axis was performed, while recording the corrected forces. The developed software allows a computing frequency up to 100 Hz with a latency of 10 ms for the online monitoring of the processed data. The evaluation of the corrected force shows a residual error of 0.347 mN ± 0.325 mN for the first and 0.176 mN ± 1.971 mN for the second test series. With the created algorithm, the impact of the extra weight on the sensor can be almost fully equalized. The highly responsive software offers a new possibility to process insertion forces and provide feedback to surgeons. Determining the influence of the tool orientation on the corrected forces is the subject of future researches

A Tool to Enable Intraoperative Insertion Force Measurements for Cochlear Implant Surgery

Objective: Residual hearing preservation during cochlear implant (CI) surgery is closely linked to the magnitude of intracochlear forces acting during the insertion process. So far, these forces have only been measured in vitro. Therefore, the range of insertion forces and the magnitude of damage-inducing thresholds in the human cochlea in vivo remain unknown. We aimed to develop a method to intraoperatively measure insertion forces without negatively affecting the established surgical workflow. Initial experiments showed that this requires the compensation of orientation-dependent gravitational forces. Methods: We devised design requirements for a force-sensing manual insertion tool. Experienced CI surgeons evaluated the proposed design for surgical safety and handling quality. Measured forces from automated and manual insertions into an artificial cochlea model were evaluated against data from a static external force sensor representing the gold standard. Results: The finalized manual insertion tool uses an embedded force sensor and inertial measurement unit to measure insertion forces. The evaluation of the proposed design shows the feasibility of orientation-independent insertion force measurements. Recorded forces correspond well to externally recorded reference forces after reliable removal of gravitational disturbances. CI surgeons successfully used the tool to insert electrode arrays into human cadaver cochleae. Conclusion: The presented positive evaluation poses the first step towards intraoperative use of the proposed tool. Further in vitro experiments with human specimens will ensure reliable in vivo measurements. Significance: Intraoperative insertion force measurements enabled by this tool will provide insights on the relationship between forces and hearing outcomes in cochlear implant surgery

Hydraulic insertions of cochlear implant electrode arrays into the human cadaver cochlea: preliminary findings

Objectives!#!(1) To evaluate the feasibility of a non-invasive, novel, simple insertion tool to perform automated, slow insertions of cochlear implant electrode arrays (EA) into a human cadaver cochlea; (2) to estimate the handling time required by our tool.!##!Methods!#!Basic science study conducted in an experimental OR. Two previously anonymized human cadaver heads, three commercially available EAs, and our novel insertion tool were used for the experiments. Our tool operates as a hydraulic actuator that delivers an EA at continuous velocities slower than manually feasible.!##!Intervention(s)!#!the human cadaver heads were prepared with a round-window approach for CI surgery in a standard fashion. Twelve EA insertion trials using our tool involved: non-invasive fixation of the tool to the head; directing the tool to the round window and EA mounting onto the tool; automated EA insertion at approximately 0.1 mm/s driven by hydraulic actuation. Outcome measurement(s): handling time of the tool; post-insertion cone-beam CT scans to provide intracochlear evaluation of the EA insertions.!##!Results!#!Our insertion tool successfully inserted an EA into the human cadaver cochlea (n = 12) while being attached to the human cadaver head in a non-invasive fashion. Median time to set up the tool was 8.8 (7.2-9.4) min.!##!Conclusion!#!The first insertions into the human cochlea using our novel, simple insertion tool were successful without the need for invasive fixation. The tool requires < 10 min to set up, which is clinically acceptable. Future assessment of intracochlear trauma is needed to support its safety profile for clinical translation

A simple tool to automate the insertion process in cochlear implant surgery

Purpose!#!Automated insertion of electrode arrays (EA) in cochlear implant surgery is presumed to be less traumatic than manual insertions, but no tool is widely available in the operating room. We sought (1) to design and create a simple tool able to automate the EA insertion process; and (2) to perform preliminary evaluations of the designed prototype.!##!Methods!#!A first prototype of a tool with maximum simplicity was designed and fabricated to take advantage of hydraulic actuation. The prototype facilitates automated forward motion using a syringe connected to an infusion pump. Initial prototype evaluation included: (1) testing of forward motion at different velocities (2) EA insertion trials into an artificial cochlear model with force recordings, and (3) evaluation of device handling, fixation and positioning using cadaver head specimens and a surgical retractor. Alignment of the tool was explored with CT imaging.!##!Results!#!In this initial phase, the prototype demonstrated easy assembly and ability to respond to hydraulic actuation driven by an infusion pump at different velocities. EA insertions at an ultra-slow velocity of 0.03 mm/s revealed smooth force profiles with mean maximum force of 0.060 N ± 0.007 N. Device positioning with an appropriate insertion axis into the cochlea was deemed feasible and easy to achieve.!##!Conclusions!#!Initial testing of our hydraulic insertion tool did not reveal any serious complications that contradict the initially defined design specifications. Further meticulous testing is needed to determine the safety of the device, its reliability and clinical applicability