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

Author(s):  
Narendran Narasimhan ◽  
Katherine E. Riojas ◽  
Trevor L. Bruns ◽  
Jason E. Mitchell ◽  
Robert J. Webster ◽  
...  

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.

2010 ◽  
Vol 4 (2) ◽  
Author(s):  
Daniel Schurzig ◽  
Zachariah W. Smith ◽  
D. Caleb Rucker ◽  
Robert F. Labadie ◽  
Robert J. Webster

Percutaneous cochlear implantation (PCI) is a recently developed minimally invasive technique that utilizes image guidance and a custom-made microstereotactic frame to guide a drill directly to the cochlea. It enables cochlear access through a single drill port, reducing invasiveness in comparison to mastoidectomy. With the reduction in invasiveness, PCI enables a corresponding reduction in visualization and space in which to work at the cochlear entry point. This precludes standard cochlear implant deployment techniques and necessitates a new insertion tool that can deploy a cochlear implant into the cochlea while working down a deep, narrow channel. In this paper, we describe a manual insertion tool that we have developed for this purpose. The tool is capable of inserting an electrode array into the cochlea using the advance off-stylet technique, using simple manual controls on its handle.


2021 ◽  
Vol 15 (3) ◽  
Author(s):  
Katherine E. Riojas ◽  
Emily T. Tran ◽  
Michael H. Freeman ◽  
Jack H. Noble ◽  
Robert J. Webster ◽  
...  

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.


Author(s):  
Andreas Hussong ◽  
Thomas S. Rau ◽  
Tobias Ortmaier ◽  
Bodo Heimann ◽  
Thomas Lenarz ◽  
...  

2018 ◽  
Vol 01 (01) ◽  
pp. 007-010
Author(s):  
Milind Kirtane ◽  
Kashmira Chavan

Abstract Introduction Different surgical approaches have been adopted for cochlear implantation, with cortical mastoidectomy–posterior tympanotomy being the most commonly followed technique. Method In this article, we describe the surgical technique for cochlear implant followed at our center, which has been successfully implemented in more than 2,500 cochlear implant surgeries. Cochlear implant surgery using the cortical mastoidectomy–posterior tympanotomy technique has been performed in more than 2,500 cases with some modifications to the original technique over a period of time. Results In spite of not using tie-down holes and securing down the receiver–stimulator with sutures, no cases of receiver–stimulator displacement or outward electrode migration have been noted with the current technique of creating a snug-fitting subperiosteal pocket along with a hook for the electrode array. Conclusion Adhering to a strict intraoperative surgical protocol plays an extremely important role in carrying out successful cochlear implant surgeries with minimal complications.


2008 ◽  
Vol 122 (4) ◽  
Author(s):  
M Viccaro ◽  
E De Seta ◽  
E Covelli ◽  
V Marvaso ◽  
R Filipo

AbstractObjective:We report a case of a rare cochlear implant complication: the introduction of the electrode array into the superior semicircular canal, with intra-operative measurements of neural response reactions suggesting reasonable functioning of the implant.Case report:A two-year old patient affected by congenital, profound, sensorineural deafness underwent bilateral cochlear implantation at the ENT clinic of the ‘La Sapienza’ University of Rome. Two Clarion 90k devices were implanted, and electrophysiological and radiological checks were performed. After the introduction of the array in the right side, neural response imaging was performed, and a neural potential was found only on two apical electrodes, at a stimulation intensity of 431 clinical units. The situation differed on the left side, where neural response imaging was present at a stimulation intensity of 300 clinical units on the two electrodes tested (one apical electrode (number three), and one middle electrode (number nine)). Intra-operative radiological assessment with a transorbital plain films was performed as usual in order to assess the position of the electrodes inside the cochlea. This radiography showed the electrode array to be in the superior semicircular canal in the right ear.Conclusion:Intra-operative monitoring tests during cochlear implant surgery play different roles; measurement of impedances and neural response imaging can evaluate the integrity of implant electrodes and the status of the electrode–cochlea interface, but it must not be the sole way in which correct positioning of the array is confirmed. In our opinion, intra-operative radiological assessment is mandatory during cochlear implant surgery.


2020 ◽  
Vol 15 (11) ◽  
pp. 1931-1939
Author(s):  
Thomas S. Rau ◽  
M. Geraldine Zuniga ◽  
Rolf Salcher ◽  
Thomas Lenarz

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.


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