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

2020 ◽  
Vol 15 (11) ◽  
pp. 1931-1939
Author(s):  
Thomas S. Rau ◽  
M. Geraldine Zuniga ◽  
Rolf Salcher ◽  
Thomas Lenarz
Keyword(s):  
Cochlear Implant ◽  
Infusion Pump ◽  
Electrode Arrays ◽  
Forward Motion ◽  
Implant Surgery ◽  
Simple Tool ◽  
Cochlear Implant Surgery ◽  
Slow Velocity ◽  
Insertion Tool ◽  
Insertion Process

Abstract 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.

scholarly journals Reliability of start and stop control of hydraulic actuation for the insertion of electrode arrays

2021 ◽  
Vol 7 (2) ◽  
pp. 109-112
Author(s):  
M. Geraldine Zuniga ◽  
Viktor Schell ◽  
Jakob Cramer ◽  
Thomas Lenarz ◽  
Thomas S. Rau
Keyword(s):  
Cochlear Implant ◽  
Infusion Pump ◽  
Electrode Arrays ◽  
Forward Movement ◽  
Average Delay ◽  
Implant Surgery ◽  
Onset Delay ◽  
Actual Movement ◽  
Cochlear Implant Surgery ◽  
And Control

Abstract Atraumatic insertions of electrode arrays (EA) into the cochlea aim to preserve natural structures and residual hearing. However, there is a limit as to how smooth and slow a surgeon can insert an EA. As a potential solution, we recently presented a tool (cochlea hydro drive, CHD) that makes use of an infusion pump to prompt and control the desired, continuous and very slow (< 1 mm/s) forward movement for such insertions. The present work further describes the onset, delay and cessation of the hydraulic actuation in response to different start and stop mechanisms, to better understand the safety of its application for cochlear implant surgery. Methods: Our previously designed tool was used to perform insertions of an EA into an artificial scala tympani model. The prototype is designed to hold an EA, which is then actuated by a standard infusion pump programmed to operate at 0.4 mm/ and 0.1 mm/s. A tubing system between the CHD and the pump includes a three-way valve. Ten insertions were operated using the functions of the pump and ten using the valve. Results: From the programmed start to the actual movement, we observed a larger average delay using the pump’s start function (5 s at 0.4 mm/s; 17 s at 0.1 mm/s) vs. opening the valve (< 0.7 s for both velocities). Moreover, the average cessation of movement with the valve closure was almost immediate (0.7 s for both velocities; this corresponds to < 0.1 mm with the slower tested velocity), as opposed to 60- 80 s delay when using the pump’s stop function. Conclusion: The use of a 3-way valve facilitates motion cessation to the high accuracy level required for cochlear implant surgery. These promising findings support future clinical translation of our tool.

Preservation of Residual Hearing After Cochlear Implant Surgery With Deep Insertion Electrode Arrays

2019 ◽  
Vol 40 (4) ◽  
pp. e373-e380 ◽  
Author(s):  
Cristina Sierra ◽  
Manuela Calderón ◽  
Eduardo Bárcena ◽  
Alexandra Tisaire ◽  
Eduardo Raboso
Keyword(s):  
Cochlear Implant ◽  
Residual Hearing ◽  
Electrode Arrays ◽  
Implant Surgery ◽  
Deep Insertion ◽  
Cochlear Implant Surgery

An automated insertion tool for cochlear implants: another step towards atraumatic cochlear implant surgery

2009 ◽  
Vol 5 (2) ◽  
pp. 163-171 ◽  
Author(s):  
Andreas Hussong ◽  
Thomas S. Rau ◽  
Tobias Ortmaier ◽  
Bodo Heimann ◽  
Thomas Lenarz ◽  
...  
Keyword(s):  
Cochlear Implant ◽  
Cochlear Implants ◽  
Implant Surgery ◽  
Cochlear Implant Surgery ◽  
Insertion Tool

Inroads Toward Robot-Assisted Cochlear Implant Surgery Using Steerable Electrode Arrays

2010 ◽  
Vol 31 (8) ◽  
pp. 1199-1206 ◽  
Author(s):  
Jian Zhang ◽  
Wei Wei ◽  
Jienan Ding ◽  
J. Thomas Roland ◽  
Spiros Manolidis ◽  
...  
Keyword(s):  
Cochlear Implant ◽  
Electrode Arrays ◽  
Robot Assisted ◽  
Implant Surgery ◽  
Cochlear Implant Surgery

A Simple Manual Roller Wheel Insertion Tool for Electrode Array Insertion in Minimally Invasive Cochlear Implant Surgery

2019 ◽  
Author(s):  
Narendran Narasimhan ◽  
Katherine E. Riojas ◽  
Trevor L. Bruns ◽  
Jason E. Mitchell ◽  
Robert J. Webster ◽  
...  
Keyword(s):  
Minimally Invasive ◽  
Cochlear Implant ◽  
Electrode Array ◽  
Invasive Procedure ◽  
Narrow Channel ◽  
Wide Field ◽  
Implant Surgery ◽  
Stereotactic Frame ◽  
Cochlear Implant Surgery ◽  
Insertion Tool

Image-guided, minimally-invasive cochlear implant surgery is a novel “keyhole” surgical approach for placing a cochlear implant electrode array eliminating the need for a wide-field mastoidectomy approach. Image guidance is used for path planning which is followed by the construction of a customized micro-stereotactic frame to drill a narrow channel from the skull surface to the cochlea. Herein, we present an insertion tool that uses roller wheels to advance the electrode array through the narrow tunnel and into the cochlea. Testing in a phantom revealed that when compared to insertions with surgical forceps, the new insertion tool was on average 26s faster, produced complete insertions more often (i.e. in 6/6 trials, vs. 1/6), and reduced array buckling (0/6 trials vs. 5/6). The tool provides a viable solution to complete the last step of this novel, minimally-invasive procedure. It also provides the advantage over previously developed manual insertion tools of enabling the surgeon to blindly actuate the roller wheel tool to advance the electrode into the tunnel. This allows the surgeon to visualize and guide insertion into the cochlea from a more advantageous visual perspective.

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

2021 ◽  
Vol 15 (3) ◽  
Author(s):  
Katherine E. Riojas ◽  
Emily T. Tran ◽  
Michael H. Freeman ◽  
Jack H. Noble ◽  
Robert J. Webster ◽  
...  
Keyword(s):  
Minimally Invasive ◽  
Cochlear Implant ◽  
Clinical Case ◽  
Tool Design ◽  
Clinical Translation ◽  
Parameter Analysis ◽  
Implant Surgery ◽  
Phantom Model ◽  
Cochlear Implant Surgery ◽  
Insertion Tool

Abstract 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.

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